Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
79
Countries
7
Sites
29
Systemic Juvenile Idiopathic Arthritis
To evaluate the efficacy of baricitinib in children with Systemic juvenile idiopathic arthritis (sJIA)
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 18 Nov 2019 → ongoing
- Decision date (initial)
- 2024-03-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507883-38-00
- EudraCT number
- 2017-004495-60
- WHO UTN
- U1111-1302-1812
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Efficacy, Safety
To evaluate the efficacy of baricitinib in children with Systemic juvenile idiopathic arthritis (sJIA)
Conditions and MedDRA coding
Systemic Juvenile Idiopathic Arthritis
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-001220-PIP01-11
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) with onset before the age of 16 years.
- Participants must have arthritis in a joint and fever lasting 2 weeks, with daily fever for 3 days, and at least 1 of the following: Evanescent erythematous rash, generalized lymph node enlargement, enlarged liver/spleen, serositis.
- Participants must have at least 2 active joints.
Exclusion criteria 6
- Participants must not have polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.
- Participants must not have persistent oligoarticular arthritis.
- Participants must not have any autoimmune inflammatory condition other than JIA.
- Participants must not have active anterior uveitis.
- Participants must not have active fibromyalgia or other chronic pain conditions.
- Participants must not have an infection.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 (PediACR30) Response Criteria at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 1568 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with commercial drug substance (baricitinib) and unit formula same as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All appropriate for clinical trial use
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 1568 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- Orphan designation
- No
PRD193167 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 1568 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 1568 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with commercial drug substance (baricitinib) and unit formula same as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All appropriate for clinical trial use
Comparator 2
SCP176238 · ATC
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 3888 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — TOCILIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11506199 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 3888 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 4
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
Placebo to match 2 mg/mL oral suspension
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
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Brightech International, LLC ORL-000001293
|
Somerset, NJ, United States | Code 10 |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Pediatric Rheumatology International Trials Organisation ORG-100030037
|
Genoa, Italy | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 10 |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
Locations
7 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruiting | 2 | 1 |
| Belgium | Ongoing, recruiting | 3 | 3 |
| Czechia | Ongoing, recruiting | 2 | 3 |
| France | Ongoing, recruiting | 7 | 5 |
| Italy | Ongoing, recruiting | 8 | 8 |
| Poland | Ongoing, recruiting | 2 | 3 |
| Spain | Ongoing, recruiting | 6 | 6 |
| Rest of world
Russian Federation, Brazil, Argentina, United Kingdom, Israel, Turkey, Japan, India, Mexico
|
— | 49 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Universitätsklinik für Kinder- und Jugendheilkunde, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Leuven
Kinderreumatologie, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Hematology oncology pediatric, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Pediatric rheumatology, Corneel Heymanslaan 10, 9000, Gent
University Hospital Olomouc
reumatology, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
reumatology, Cernopolni 9, Cerna Pole, Brno-Sever
Vseobecna Fakultni Nemocnice V Praze
reumatology, Ke Karlovu 455/2, Nove Mesto, Prague 2
Centre Hospitalier Universitaire De Poitiers
Rhumatologie, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Service Rhumatologie, 59 Boulevard Pinel, 69500, Bron
Hopital Necker Enfants Malades
Centre d'Investigation Clinique, 149 Rue De Sevres, 75015, Paris
Bicetre Hospital
Rhumatologie pediatrique et CEREMAIA, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Nimes
Service de pédiatrie, Place Du Professeur Robert Debre, 30900, Nimes
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Reumatologia Pediatrica, Via Gaetano Pini, 9, Milano
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Pediatria ad indirizzo reumatologico, Via Dei Vestini Snc, 66100, Chieti
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Clinica Pediatrica, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Pediatria media intensità di cura, Via Della Commenda 12, 20122, Milan
Giannina Gaslini Institute For Scientific Hospitalization And Care
Clinica Pediatrica e Reumatologia, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento Scienze Mediche Traslazionali, Via Sergio Pansini 5, 80131, Naples
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Clinica Pediatrica, Via Dell' Istria 65/1, 34137, Trieste
ARNAS Civico Di Cristina Benfratelli
Pediatria, Piazza Nicola Leotta 4, 90127, Palermo
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji, Klinika Reumatologii Wieku Rozwojowego
Hospital, ul. Spartanska 1, 02-637, Warszawa
CSK, Uniwersyteckie Centrum Pediatrii im. M.Konopnickiej
Hospital, ul. Sporna 36/50, 91-738, Lodz
Szpital Dzieciecy Sw. Ludwika III Oddział Kliniczny Pediatrii Reumatologii z pododdziałem alergologi
Hospital, ul Strzelecka 2, 31-503, Krakow
Hospital Infantil Universitario Nino Jesus
Pediatric Rheumatology, Avenida Menendez Pelayo 65, 28009, Madrid
University Hospital Virgen Del Rocio S.L.
Pediatric Inmunology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Pediatric Rheumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Pediatric Rheumatology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Ramon Y Cajal
Pediatric Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Sant Joan De Deu Barcelona Hospital
Pediatric Rheumatology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
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 | 2020-03-12 | ||||
| Belgium | 2020-08-10 | 2023-07-12 | |||
| Czechia | 2020-02-25 | 2021-10-06 | |||
| France | 2019-11-18 | 2020-08-27 | |||
| Italy | 2019-11-20 | 2020-11-19 | |||
| Poland | 2020-10-09 | 2020-11-09 | |||
| Spain | 2020-03-09 | 2022-09-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 183 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-507883-38-00_redacted | f |
| Protocol (for publication) | Patient Documents Copyright Template | 1 |
| Recruitment arrangements (for publication) | Blank document Template_v1 | 1 |
| Recruitment arrangements (for publication) | K1_Blank Statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Referral letter | 1.0 |
| Recruitment arrangements (for publication) | K2__Recruitment material_Comic_Older Child_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Microsampling at home instructions_FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Microsampling at home sheet_ FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Activity book_DU | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Activity book_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Activity book_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Older Children_DU_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Older Children_ENG_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Older Children_FR_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Younger Children_DU_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Younger Children_ENG_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Comic Book Younger Children_FR_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Comic_Younger child_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card_DU | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Thank You Card_ FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Thank You Card_DU | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Guide_DU_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Guide_ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Guide_FR_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Reruitment material_List of Sites_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_assent_NON-PoC Older Child_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_assent_PoC Older Child_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_assent_Younger Child_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_GP Letter_IT_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_main ICF_NON-PoC_child_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_main ICF_NON-PoC_Parent_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_main ICF_PoC_child_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_main ICF_PoC_Parent_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and Assent ICF_NON-PoC Older Child_15Mar2024_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and Assent ICF_PoC Older Child_15Mar2024_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and Assent ICF_Younger Child_01Mar2024_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum POC cohort EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum POC cohort FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum POC cohort NL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF assent form non PK_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children POC DU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children POC EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children POC FR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children Without POC DU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children Without POC EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children Without POC FR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF assent form PK_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Younger Children DU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Younger Children EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Younger Children FR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF assent form Younger_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF genetic adults_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF genetic parents_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF DU_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF ENG_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF FR_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1-5yo | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_11-14yo_02fev2024_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_11-14yo_15oct2021_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17yo_03fev2023_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17yo_08fev2024_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6-10yo_02fev2024_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6-10yo_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum PK_Adults_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum PK_Parents_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Genetic research_highlighted_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Genetic research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults_Old_Version_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 12-14y nonPK_highlighted_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 12-14y nonPK_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 12-14years PK_highlighted_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 12-14years PK_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17years nonPK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17years nonPK_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17years PK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17years PK_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child_POC PK_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_adult | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_parents | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult nonPK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult nonPK_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult PK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult PK_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parents nonPK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parents nonPK_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parents PK_highlighted_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parents PK_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_mineur majeur_08fev2024_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NON-PoC_Parent_Redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child_POC PK_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Children Assent nonPK_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Children Assent PK_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_Old_ Version_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_POC PK_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_patient mineur majeur_03fev2023_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PdC Adults_Old_Version_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PdC Adults_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PdC Parents_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PoC_child 14-17y_Redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PoC_Parent_Redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_rep legaux_03fev2023_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Rep Legaux_08fev2024_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Children Assent_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and_ICF_NON-PoC_child 14-17y_Redacted | 13 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Activity book | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_BARICITINIB-IFU-CT-PHASE3 | 4.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_direction for use_ediary | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_JAHU-IT-IT-VG-V2-09FEB21_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Microsampling At-Home Instructions | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Microsampling At-Home Intake Sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Card | N/A |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Retention Materials Bag Information | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_thank you card | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_UCT_OLDER_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_UCT_YOUNGER_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_BARICITINIB IFU_FR | 4.0 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _directions for use_ediary | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material subject_Thank you card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material UCT_OLDER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material UCT_YOUNGER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material__TOCI Instructions for Use_ BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Administration log | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bag Information | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direction for use ediary | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direction for use IP | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_form | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions for use | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_JUVE BALM | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Microsampling At-Home Instructions | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Microsampling At-Home Intake Sheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MITRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient cards | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient information ard | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment Arrangement_Clean | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_TOCI Instructions for Use_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_TOCI Instructions for Use_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_15FEB21 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information_Toci administration log_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information_Toci administration log_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information_Toci administration log_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Visit Guide_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Study Drug Administration Log | 1 |
| Subject information and informed consent form (for publication) | L2_Study Drug Administration Log_ 27May 2024 | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card | 2 |
| Subject information and informed consent form (for publication) | L3_Patient ID_Emminger_Redacted | 2 |
| Subject information and informed consent form (for publication) | L3_Rationale for DOB data collection_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L3_Rationale for race ethnicity data collection_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_baricitinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Tocilizumab | n/a |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT_2023-507883-38-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507883-38-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ 2023-507883-38-00_Redacted | F |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2023-507883-38-00_de-AUT_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-507883-38-00_Redacted | F |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-507883-38-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-507883-38-00 _Redacted | f |
| Synopsis of the protocol (for publication) | JAHU_Protocol Synopsis f BE DU 2023-507883-38-00_redacted | f |
| Synopsis of the protocol (for publication) | JAHU_Protocol Synopsis f BE GER_2023-507883-38-00_redacted | f |
| Synopsis of the protocol (for publication) | JAHU_Protocol Synopsis f_BE FR_2023-507883-38-00_2024_redacted | f |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-17 | Spain | Acceptable 2024-02-20
|
2024-02-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-22 | Spain | Acceptable 2024-07-16
|
2024-07-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-13 | Spain | Acceptable 2024-09-27
|
2024-09-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-23 | Acceptable | 2024-12-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-24 | Acceptable | 2025-01-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-14 | Acceptable | 2024-12-18 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-10 | Acceptable | 2025-02-10 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-21 | Spain | Acceptable | 2025-02-21 |
| 9 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-24 | Acceptable | 2025-05-12 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-02-25 | Acceptable | 2025-03-25 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-28 | Spain | Acceptable | 2025-04-08 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-06 | Spain | Acceptable | 2025-08-06 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-26 | Acceptable | 2026-01-26 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-02 | Acceptable | 2026-04-02 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-05-27 | Acceptable | 2026-05-27 |