Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
88
Countries
9
Sites
31
Moderately to Severely Active Crohn's Disease
To evaluate the efficacy and safety of guselkumab in pediatric participants with CD at the end of maintenance therapy among participants who were in clinical response to guselkumab at Week 12
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 5 Mar 2024 → ongoing
- Decision date (initial)
- 2024-09-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, LLC
External identifiers
- EU CT number
- 2023-504735-41-00
- EudraCT number
- 2021-006282-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Efficacy
To evaluate the efficacy and safety of guselkumab in pediatric
participants with CD at the end of maintenance therapy among
participants who were in clinical response to guselkumab at Week 12
Conditions and MedDRA coding
Moderately to Severely Active Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Regulatory references
- Scientific advice from competent authorities
- EMA Regulatory Submissions Expediter Limited
- EMA paediatric investigation plan (PIP)
- EMEA-001523-PIP05-19
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [≥] 30)
- Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) during screening into this study
- Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor
Exclusion criteria 3
- Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
- Participants must not have an abscess
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Clinical remission at Week 52 (defined as PCDAI score ≤10)
- Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10890563 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Guselkumab- Solution for infusion- 10 mg/ml
PRD8913651 · Product
- Active substance
- Guselkumab
- Other product name
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10890564 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
PRD2827309 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 3
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- Clinical Registry Group
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- Clinical Registry Group
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 11, Code 12, Code 2 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
Locations
9 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1 | 1 |
| Belgium | Ongoing, recruiting | 4 | 4 |
| France | Ongoing, recruiting | 4 | 4 |
| Italy | Ongoing, recruiting | 5 | 7 |
| Netherlands | Ongoing, recruiting | 1 | 1 |
| Norway | Ongoing, recruiting | 4 | 4 |
| Poland | Ongoing, recruiting | 4 | 4 |
| Portugal | Ongoing, recruiting | 3 | 3 |
| Spain | Ongoing, recruiting | 4 | 3 |
| Rest of world
United States, Israel, Australia, Japan, Brazil, United Kingdom, Korea, Republic of, Canada
|
— | 58 | — |
Investigational sites
Medical University Of Vienna
Department of Pediatric Nephrology and Gastroenterology, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Brussel
Pediatric gastroenterology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Gent
Pediatric gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Pediatric gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Pediatric gastroenterology, Herestraat 49, 3000, Leuven
Assistance Publique Hopitaux De Paris
Pediatric, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire Amiens Picardie
Pediatric, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Lille
Pediatric, Avenue Eugene Avinee, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Pediatric, 48 Boulevard Serurier, 75019, Paris
Azienda Ospedaliera Universitaria Meyer IRCCS
Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Unita Sanitaria Locale Di Bologna
Pediatria, Largo Bartolo Nigrisoli 2, 40133, Bologna
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Epatologia e Gastroenterologia Pediatrica e dei Trapianti, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Pediatrics Unit, Spalto Marengo 46, 15121, Alexandria
Ospedale Pediatrico Bambino Gesu
OU di Epatologia, Gastroenterologia e Nutrizione, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Gastroenterologia ed Epotologia Pediatrica, Viale Del Policlinico 155, 00161, Rome
ASST Fatebenefratelli Sacco
Gastroenterologia e Nutrizione, Via Lodovico Castelvetro 32, 20154, Milan
Erasmus Medisch Centrum 1
Research Facility, Dr Molewaterplein 40, 3015 GD, Rotterdam
Akershus University Hospital
Cardiology, Sykehusveien 27, 1478, Lorenskog
Oslo University Hospital HF
Doctor of Medicine, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Doctor of Medicine, P. O. Box 3250, Torgarden, Trondheim
Universitetssykehuset Nord-Norge HF
Doctor of Medicine, P. O. Box 100, 9038, Tromsoe
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Gabinet Lekarski Bartosz Korczowski
N/A, ul. Litewska 4A/7, 35-302, Rzeszów
Instytut Pomnik Centrum Zdrowia Dziecka
Klinika Gastroenterologii, Hepatologii, Zaburzeń odżywiania i Pediatrii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Unidade Local de Saude de Sao Joao E.P.E.
Serviço de Pediatria, Alameda Professor Hernani Monteiro, 4200-319, Porto
CCAB Centro Clinico Academico Braga Associacao
Serviço de Pediatria, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santa Maria E.P.E.
Serviço de Pediatria, Avenida Professor Egas Moniz, 1649-035, Lisbon
Parc Tauli Hospital Universitari
Pediatric Gastroenterology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitario Y Politecnico La Fe
Gastroenterology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Pediatric Gastroenterology, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-09-30 | 2025-11-11 | |||
| Belgium | 2024-07-26 | 2024-10-02 | |||
| France | 2024-07-10 | 2024-12-13 | |||
| Italy | 2024-05-17 | 2024-06-10 | |||
| Netherlands | 2024-09-20 | 2025-11-21 | |||
| Norway | 2024-03-05 | 2024-03-13 | |||
| Poland | 2024-03-27 | 2024-04-04 | |||
| Portugal | 2024-09-09 | 2025-01-24 | |||
| Spain | 2024-06-26 | 2024-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 565 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Clarification Letter_PLATFORM_2023-504735-41-00_red | NA |
| Protocol (for publication) | D1_Protocol_2023-504735-41-00_red | AM4 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Child_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_ FR_FR _2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC Observer_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_EN_2023-504735-41-00 | 3 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Average Abdominal Pain_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being Child_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_NO_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_FrequencyTrans_Paper_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_EN_2023-504735-41-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate subject facing_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch subject facing_PT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_AT_2023-504735-41-00 | N/A |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_BE_FR_2023-504735-41-00 | N/A |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_BE_NL_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_EN_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_ES_2023-504735-41-00 | N/A |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_FR_FR_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_NO_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_PL_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_PT_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_IT_2023-504735-41-00 | NA |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Trans_Paper_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_AT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_BE_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_BE_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_EN_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_ES_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_FR_FR_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_IT_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_NL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_PL_2023-504735-41-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_AT_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_BE-FR_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_BE-NL_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_EN_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_ES_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_FR_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_IT_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_NL_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_NO_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_PL_2023-504735-41-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Patient Diary_PT_2023-504735-41-00 | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitment and Consent _Blank document for CTIS placeholders for transitional trial | 1.1 |
| Recruitment arrangements (for publication) | K1_2023-504735-41_Recruitment and informed consent form | 1 |
| Recruitment arrangements (for publication) | K1_Bank Transfer FAQ_AUT | 10.0 |
| Recruitment arrangements (for publication) | K1_Bank Transfer Standard Message Template_AUT | 10.1 |
| Recruitment arrangements (for publication) | K1_Blank doc for CTIS placeholders for transitional trial_san | 1.1 |
| Recruitment arrangements (for publication) | K1_ClinCard KYC and Card Activation Msg Templates_AUT | 10.1 |
| Recruitment arrangements (for publication) | K1_CNTO1959PBCRD3007_Recruitment Arrengements_NLD_San | V2.0 |
| Recruitment arrangements (for publication) | K1_KYC Identity Verification for ClinCard_AUT | 10.1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_san | V1.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_San | Italy |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Spain | V1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_V01_san | V01 |
| Recruitment arrangements (for publication) | K2 C-SSRS-Baseline Screening_2subscales_San | 5.3 |
| Recruitment arrangements (for publication) | K2 C-SSRS-Since Last Assessed_2subscales_San | 5.2 |
| Recruitment arrangements (for publication) | K2 CDAI_Worst_Abdominal Pain_San | 1 |
| Recruitment arrangements (for publication) | K2 CDAI_Worst_Abdominal_Pain_Child_San | 1 |
| Recruitment arrangements (for publication) | K2 CDAI_Worst_Abdominal_Pain_Observer_San | 1 |
| Recruitment arrangements (for publication) | K2 CDI-2-Self Report SHORT Response Form_San | 1.0 |
| Recruitment arrangements (for publication) | K2 Fatigue_San | 2 |
| Recruitment arrangements (for publication) | K2 Instructions_for_ObsRO_Items_Crohns_San | 1 |
| Recruitment arrangements (for publication) | K2 Milestone Certificate_San | 1 |
| Recruitment arrangements (for publication) | K2 PedsQL_4_0_Core_Acute_A_San | 4.0 |
| Recruitment arrangements (for publication) | K2 PedsQL-4_0_Core_Acute_PT_WN39571_San | 1 |
| Recruitment arrangements (for publication) | k2 PedsQL-4_0_Core_Acute_PYC_WN39571_San | 1 |
| Recruitment arrangements (for publication) | K2 PedsQL-4_0-Core_Acute_C_San | 4.0 |
| Recruitment arrangements (for publication) | K2 PGI-C_Crohns_Child_San | 1 |
| Recruitment arrangements (for publication) | K2 PGI-C_Crohns_Observer_San | 1 |
| Recruitment arrangements (for publication) | K2 PGI-C_Crohns_San | 1 |
| Recruitment arrangements (for publication) | K2 PGR-S_Crohns_Child_San | 1 |
| Recruitment arrangements (for publication) | K2 PGR-S_Crohns_Observer_San | 1 |
| Recruitment arrangements (for publication) | K2 PGR-S_Crohns_San | 1.1 |
| Recruitment arrangements (for publication) | K2 Tanner Stage Form_Female_Self-Reported_San | 1.0 |
| Recruitment arrangements (for publication) | K2 Tanner Stage Form_Male_Self-Reported_San | 1 |
| Recruitment arrangements (for publication) | K2 Urgency NRS_San | 1 |
| Recruitment arrangements (for publication) | K2 Urgency_Crohns_Child version_San | 1 |
| Recruitment arrangements (for publication) | K2 Urgency_Observer version_San | 1 |
| Recruitment arrangements (for publication) | K2 WPAI-CIQ-CD_San | 2 |
| Recruitment arrangements (for publication) | K2_ Master Protocol_ParentGuardian Brochure_TC V02NLDnl01 to V02NLDnl02 | 02NLD02 |
| Recruitment arrangements (for publication) | K2_2023-504735-41_Parent guardian brochure_redacted | 03FRAfr |
| Recruitment arrangements (for publication) | K2_Abdominal Pain NRS_San | 1 |
| Recruitment arrangements (for publication) | K2_Bank Transfer | V10.0 |
| Recruitment arrangements (for publication) | K2_Bank Transfer Standard Message | V10.0 |
| Recruitment arrangements (for publication) | K2_KYC and Card Activation Message templates | V10.0 |
| Recruitment arrangements (for publication) | K2_KYC Identity Verification for ClinCard | V10.1 |
| Recruitment arrangements (for publication) | K2_Parent Guardian Brochure_red_san | 03NOR(no) |
| Recruitment arrangements (for publication) | K2_Parent Guardian Brochure_redacted | V03AUT(de) |
| Recruitment arrangements (for publication) | K2_Parent-Guardian Study Guide_Red-San | V03 ITA |
| Recruitment arrangements (for publication) | K2_PLATFORMPBCRD3001_ParentGuardian Brochure_Red_San | V03NLD01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Study Assistance Items_san | V01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C_SSRS_Baseline Screening_2subscales_san | 14.01.09 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C_SSRS_Since Last Assessed_2subscales_san | 14.01.09 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CDAI_Average Abdominal Pain_San | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CDI_Self Report_san | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Protocol_Parent Guardian Brochure_Red-San | V03 ITA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_2_red | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_en_red | V03BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_fr_red | V03BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_nl_red | V03BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parents_Guardians Brochure_PL_redacted | V03POL01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient ID Card_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient-facing _Screening_Fecal Sample Collection Instructions_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient-facing_Non-Screening_Fecal Sample Collection Instructions_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGI-C_Crohns_Child_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGI-C_Crohns_Observer_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGI-C_Crohns_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGR-S_Crohns_Child_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGR-S_Crohns_observer_san | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGR-S_Crohns_san | 1.0 |
| Recruitment arrangements (for publication) | K2_recrutiment material_Study Assistance Items_PL_san | V01 |
| Recruitment arrangements (for publication) | K2_SchoolEmployer Letter_San | 1 |
| Subject information and informed consent form (for publication) | _L1_SIS and ICF_Pregnant Partner_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_CNTO1959PBCRD3007 Parental ICF_FRA_redacted | V5.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_CNTO1959PBCRD3007_12-17y_FRA_redacted | V6.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_CNTO1959PBCRD3007_6-11y_FRA_redacted | V5.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_CNTO1959PBCRD3007_PP_FRA_redacted | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_CNTO1959PBCRD3007_Turning 18_FRA_redacted | V5.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_FSR_12-17y_FRA_redacted | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_FSR_Parental_FRA_redacted | V3.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_FSR_Turning 18_FRA_redacted | V3.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Greenphire_Parental_FRA_san | 2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Greenphire_Turning 18_FRA_san | 2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Platform 12-17y_FRA_redacted | 5.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Platform Parental_FRA_redacted | V5.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Platform Turning 18_FRA_redacted | V5.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Platform_2-5y_FRA_redacted | V4.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-504735-41_ICF_Platform_6-11y_FRA_san | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Janssen_12-17_red | 6.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Janssen_6-11 years_red | 5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Greenphire | V1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Janssen_Parental-Turning18_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Assent 6-11 years_san | V4.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Parental and Turning 18_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Master Assent 12 -17 years_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF PP | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Turning 18 Main | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Assent 12-15 years old_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Assent 5-11 years old | V4.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_ Addendum Turning 18 years_Red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_16 - 17 years_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 12-15 years old_red | V6.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 16 -17 years_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 5-11 years old_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum Parental_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Parental_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Pregnancy Addendum_red | V3.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Turning 18 years_Red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V1.0NOR1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum Assent 13-14_redacted | V6.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum_PP | V3.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Janssen _12-16y_Assent_ICF_nl_red_san | V6.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Janssen _Parental ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Janssen _PP_ ICF_nl_red_san | V3.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Assent 15-17_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Assent 8 -12_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Parental_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Turning 18_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 yo_Red-San | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 6-11 yo_San | V4.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_12 to 17_Addendum_red_san | V6.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_6 to 11 years_Addendum_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen CONFIDENTIAL Addendum 13-18 years old_PL_redacted | V6.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen CONFIDENTIAL Addendum 6-13 years old_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen CONFIDENTIAL ICF Parental Addendum_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen CONFIDENTIAL PP ICF Addendum_PL_san | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen CONFIDENTIAL Turning 18 ICF Addendum_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_12-17 Assent ICF_en_red | V6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_12-17 Assent ICF_fr_red | V6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_12-17 Assent ICF_nl_red | V6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_6-11 Assent ICF_en_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_6-11 Assent ICF_fr_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_6-11 Assent ICF_nl_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Assent 12-17 yo_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Assent 6-11 yo_Red-San | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Parental Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Parental Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Turning 18 yo Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Addendum to Turning 18 yo Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Adult ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Parental Turning 18 ICF_en_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Parental Turning 18 ICF_fr_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Parental Turning 18 ICF_nl_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Pregnancy_San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Pregnant Partner ICF_en_san | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Pregnant Partner ICF_fr_san | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_Pregnant Partner ICF_nl_san | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Janssen_up to 12y Assent_ICF_nl_red_san | V5.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 13-14_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 13-18 years_PL_redacted | V5.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 15-17 Greenphire | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 15-17_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 6-13 years old_PL_san | V4.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 8-12 | V4.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_12-17 years_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_2-5 years_red_san | V4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_6 to 11 years_san | V4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Addendum_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Turning 18_redacted | V5.0AUT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-16 Assent ICF_nl_red_san | 5.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_en_san_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_fr_san_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_nl_san_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_en_san_red | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_fr_san_red | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_nl_san_red | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Assent 2-5 yo_red-san | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Main ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_en_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_fr_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_nl_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_en_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_fr_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_nl_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 yo Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_up to 12_ Assent ICF_nl_red_san | V4.0NLD3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR _Participants turning 18_red_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR Assent_12-17 yo_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Assent 13-18 Years_PL_redacted | V3.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Parental_PL_redacted | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Parental_red_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR Turning to 18 ICF_PL_redacted | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Assent_12 to 17 years_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Parental_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Turning 18 yo_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental Greenphire | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental ICF_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participants turning 18_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP | V1.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Addendum_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_PL_san | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Greenphire | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 ICF_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Years and Parental Greenphire ICF_Clean_san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Years and Parental Greenphire ICF_PL_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 yo Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2 _Patient_card_San | 02 |
| Subject information and informed consent form (for publication) | L2 IP Instructions for Handling IFU FVP_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2 IP Instructions for Handling IFU PFS_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2 Patient Study Guide_San | 1 |
| Subject information and informed consent form (for publication) | L2 Patient-facing _Screening_Fecal Sample Collection Instructions_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Patient_CDI-2-Self Report SHORT Response Form_FRA | NA |
| Subject information and informed consent form (for publication) | L2_ Patient_Fatigue Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_ Patient_Fatigue_FRA | 2 |
| Subject information and informed consent form (for publication) | L2_ Patient_WPAI-CIQ-CD_FRA | 2 |
| Subject information and informed consent form (for publication) | L2_At Home Administration Diary Weight Range 10-25kg_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_At Home Administration Diary Weight Range 25-40kg_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_At Home Administration Diary Weight Range 40kg_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_GP Letter_San | 2.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire packet with Data Privacy_for EC | v10.0 |
| Subject information and informed consent form (for publication) | L2_Instructions for use guselkumab_placebo Pre-filled pen_VarioJect_PL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Instructions for use guselkumab_placebo Pre-filled syringe_PL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ A-1130-0120-5151QRG | v1_ptPT |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ CDAI_Worst Abdominal Pain | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Fatigue_Observer version | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_3D Secure Terms of Use_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Abdominal Pain NRS | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Abdominal Pain NRS_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Baseline Screening | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Baseline Screening_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Since Last Assessed | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Since Last Assessed_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Worst Abdominal Pain_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Worst Abdominal_Pain_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Worst Abdominal_Pain_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Worst_Abdominal_Pain_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Worst_Abdominal_Pain_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDI 2 Self Report | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDI-2-Self Report SHORT Response Form_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder FAQ_PL_san | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg Templates | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg Templates_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Website Screenshots_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Card_Carrier_PL_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Fee_Schedule_PL_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Generic_Image_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Privacy Policy_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CNTO1959PBCRB3007_ Weight Range 40kg_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CNTO1959PBCRB3007_Weight Range 10-25kg_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CNTO1959PBCRB3007_Weight Range 25-40kg_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CNTO1959PBCRD3007 IFU FVP_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CNTO1959PBCRD3007 IFU PFS_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EC_packet_Data_Privacy_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue | v2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue_PL_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Card Carrier | V10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Cardholder FAQ | V11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard EC Submission Overview | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Privacy Policy_TPML | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Website Screenshots | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Dispute Form | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Fee Schedule | V10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Secure Terms of Use | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Guide to the eDiary ORG_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Home Diary 10-25_PL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Home Diary 25-40_PL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Home Diary 40_PL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_i2c EU Dispute Form_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions_for_ObsRO_Items_Crohns_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Janssen_Study Guide for Parents_ Guardians_PL_redacted | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter to School Employer_PL_san | V01POL01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MACARONI-23_Patient-facing Non-Screening | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MACARONI-23_Patient-facing Screening | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Milestone Certificate_PL_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParentGuardian Study Guide_red | V03PRT01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID Card | V02PRT(pt) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID card_PL_san | V02POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Stool Collection Materials | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Acute-Core-PYC_PL_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute_A_PL_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-A_AU | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-C | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-C_PL_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-PT | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-PT_PL_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PedsQL-Core-Acute-PYC | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns | v1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_PL_san | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Sample_ICF_Notice_EU_PL_san | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Stool Sampling Instructions for Non-Screening Visit_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Stool Sampling Instructions for Screening Visit_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Assistance Items | 01Global |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tanner Stage Form_Female_Self-Reported | L1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tanner Stage Form_Female_Self-Reported_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tanner Stage Form_Male_Self-Reported | L1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tanner Stage Form_Male_Self-Reported_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency NRS | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency NRS_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency_Crohns_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency_Crohns_Child version_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency_Observer version_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI-CIQ-CD | v2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI-CIQ-CD_PL_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GP Letter_Red-San | ITA V3.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Abdominal Pain Numeric Rating Scale_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Administration diary weight 10 to 25kg_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Administration diary weight 25 to 40kg_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Administration diary weight up to 40kg_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_C-SSRS baseline Screening_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_C-SSRS since last assessed_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_CDAI Worst Abdominal Pain Child_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_CDAI Worst Abdominal Pain Observer_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_CDAI Worst Abdominal Pain_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_EC Submission Overview_FRA | 9.0 |
| Subject information and informed consent form (for publication) | L2_Patient_eDiary study guide_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Fatigue Observer_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_Fecal collection instructions Non screening_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Fecal collection instructions screening_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Automatic transfers FAQ_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_CardHolder FAQ_FRA | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Carrier_FRA | 3 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Clincard_FRA | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Contact Card_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Fee schedule_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Msg Template_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Travel Ref Guide_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Instructions for Crohn questions_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Instructions for use Prefilled Pen_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Instructions for use Prefilled syringe_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Milestone certificate_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Parent guardian brochure_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Parental study guide_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Patient Card_FRA | 02FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Pediatric QL-Acute A Teen_FRA | 4.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Pediatric QL-Acute C Child_FRA | 4.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Pediatric QL-Acute PT Toddlers_FRA | 4.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Pediatric QL-Acute PYC Young Child_FRA | 4.0 |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C Observer_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S Observer_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S_FRA | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient_School employer letter_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Tanner Stage-Female-Self-reported_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Tanner Stage-Male-Self-reported_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Urgency Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_Urgency Observer_FRAfr_V1_20230214_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_Urgency_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient-facing_Non Screening_Fecal Sample Collection Instructions_san | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA_2023-504735-41-00_de-BE_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-504735-41-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT_2023-504735-41-00_ISA_red | AM4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT_2023-504735-41-00_Platform_red | AM3 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-19 | Netherlands | Acceptable with conditions 2024-08-13
|
2024-08-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-24 | Netherlands | Acceptable 2025-06-02
|
2025-06-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-23 | Acceptable 2025-06-02
|
2025-06-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-09 | Netherlands | Acceptable | 2025-07-14 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-24 | Acceptable | 2025-07-24 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-30 | Acceptable | 2025-09-25 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-25 | 2025-09-25 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-17 | Netherlands | Acceptable 2025-12-10
|
2025-12-10 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-12 | Netherlands | Acceptable 2025-12-10
|
2026-02-12 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-27 | Acceptable | 2026-05-25 |