Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruitment ended
Participants planned
463
Countries
11
Sites
42
Rheumatoid Arthritis
To evaluate the efficacy and safety of upadacitinib and adalimumab, in adult subjects with rheumatoid arthritis on background MTX, following an inadequate response or intolerance to a single TNFi.
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 7 Nov 2023 → ongoing
- Decision date (initial)
- 2023-10-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy and safety of upadacitinib and adalimumab, in adult subjects with rheumatoid arthritis on background MTX, following an inadequate response or intolerance to a single TNFi.
Conditions and MedDRA coding
Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adult individuals, ≥ 18 years old at screening.
- Diagnosis of RA for ≥ 3 months prior to screening based on the 2010 ACR/EULAR classification criteria for RA.
- Subject have been treated for ≥ 3 consecutive months prior to screening with 1 TNFi (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of subjects who were intolerant to 1 TNFi will be allowed to enroll. • Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
- Subject meets both of the following disease activity criteria: a) ≥ 6 swollen joint (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline; b) hsCRP ≥ 3 mg/L (central lab, ULN 2.87 mg/L) at screening.
- Subjects must have been on oral or parenteral MTX therapy ≥ 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or ≥ 10 mg/week in subjects intolerant of MTX at doses ≥ 15 mg/week) for ≥ 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
Exclusion criteria 5
- Subject with prior exposure to any JAK inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, filgotinib, and deucravacitinib).
- Subject treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or is currently enrolled in another interventional clinical study.
- Subject must not have any of the following medical diseases or disorders: - Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aortocoronary bypass surgery. - History of moderate to severe congestive heart failure (NYHA Class III or IV). - Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) > 450 msec (males) or > 470 msec (females). - History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix. - History of GI perforation (other than appendicitis or penetrating injury), diverticulitis or significantly increased risk for GI perforation per investigator judgment. - Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded. - History of demyelinating disease such as multiple sclerosis. - History of an organ transplant which requires continued immunosuppression.
- Current or past history of infection including: - Two or more episodes of herpes zoster, or 1 or more episodes of disseminated herpes zoster; - One or more episodes of disseminated herpes simplex (including eczema herpeticum); - HIV infection defined as confirmed positive HIV Ab and Ag test; - Active TB or meet TB exclusionary parameters; - Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baseline; - Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study; - COVID-19 infection: For any asymptomatic subject who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry. - Subjects must not have evidence of active HBV or HCV infection.
- Subject with any exposure to: - adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab. - an approved or investigational non-TNFi bDMARD or tsDMARD
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is achievement of DAS28-CRP ≤ 3.2 at Week 12. DAS28-CRP will be calculated based on the values of TJC28, SJC28, PtGA, and hsCRP.
Secondary endpoints 5
- Achievement of ACR50 at Week 12. Achievement of ACR50 response will be determined based on 50% or greater improvement in TJC68 and SJC66 and ≥ 3 of the 5 measures of Patient's Assessment of Pain (past week, NRS), Patient's Global Assessment of Disease Activity (PtGA [past week, NRS]), Physician's Global Assessment of Disease Activity (PhGA [NRS]), HAQ-DI, or hsCRP.
- Achievement of DAS28-CRP < 2.6 at Week 12
- Change from baseline in DAS28-CRP at Week 12
- Change from baseline in Patient's Assessment of Pain at Week 12
- Change from baseline in HAQ-DI at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD3232825 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 8
Humira 40 mg solution for injection in pre-filled pen
PRD5952371 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/018
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled pen
PRD5952369 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/016
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952367 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/014
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952365 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/012
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952368 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/015
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952366 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/013
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled pen
PRD5952372 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/019
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled pen
PRD5952370 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/017
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
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
Auxiliary 1
-
L04A · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL AND IV
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04A — IMMUNOSUPPRESSANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management, E-data capture |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Code 14, Interactive response technologies (IRT) |
Locations
11 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 5 |
| Bulgaria | Ongoing, recruitment ended | 24 | 7 |
| Croatia | Ongoing, recruitment ended | 1 | 1 |
| France | Ended | 18 | 6 |
| Germany | Ongoing, recruitment ended | 15 | 4 |
| Greece | Ongoing, recruitment ended | 12 | 3 |
| Hungary | Ended | 15 | 4 |
| Italy | Ended | 9 | 3 |
| Portugal | Ongoing, recruitment ended | 9 | 3 |
| Romania | Ongoing, recruitment ended | 18 | 3 |
| Spain | Ended | 15 | 3 |
| Rest of world
China, South Africa, Colombia, Korea, Republic of, Serbia, Mexico, Chile, Canada, Brazil, United Kingdom, Puerto Rico, United States, Argentina, Japan
|
— | 315 | — |
Investigational sites
Reumaclinic
NA, Jaarbeurslaan 21/22, 3600, Genk
Cliniques Universitaires Saint-Luc
NA, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az St-Jan Brugge-Oostende A.V.
NA, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
NA, Corneel Heymanslaan 10, 9000, Gent
CHU De Liege
NA, Avenue De L'hopital 1, 4000, Liege
Military Medical Academy
N/A, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
University Multiprofile Hospital For Active Treatment Kaspela EOOD
N/A, Zapaden District, Sofia Str 64, Plovdiv
Dkc Fokus-5 Lzip OOD
N/A, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Diagnostic Consulting Center XVII Sofia Ltd.
N/A, Bulevard Evlogi I Hristo Georgievi 108, 1505, Sofiya
University Multiprophy Hospital For Active Treatment - Plovdiv AD
N/A, Bulevard Bilgariya 234, 4003, Plovdiv
UNIMED Medical Center EOOD
N/A, Ulitsa Siedinenie 42, 4023, Plovdiv
Dkc Fokus-5 Lzip OOD
N/A, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Centre Hospitalier Universitaire De Toulouse
NA, Place Du Docteur Joseph Baylac, 31000, Toulouse
CHU De Rouen
NA, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire Amiens Picardie
NA, 1 Place Victor Pauchet, 80080, Amiens
Centre Hospitalier Regional D'orleans
NA, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire De Montpellier
NA, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nice
NA, 30 Voie Romaine, 06000, Nice
Rheumazentrum Ratingen
NA, Calor-Emag-Strasse 3, 40878, Ratingen
Rheumatologisch-immunologische Praxis PD Dr. med. Jacqueline Detert
NA, Lychener Strasse 65, 17268, Templin
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
NA, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Klinische Forschung Im Medizinischen Versorgungsalltag GbR
NA, Bahnhofstrasse 32, 82152, Planegg
University General Hospital Of Heraklion
Internal Medicine/Rheumatology Department, Stavrakia And Voutes, 715 00, Heraklion
Laiko General Hospital Of Athens
1st department of Propaedeutic and Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
University General Hospital Attikon
4th Department of Internal Medicine, Rimini Street 1, 124 62, Athens
Mav Korhaz Es Rendelointezet Szolnok
NA, Verseghy Ut 6-8, 5000, Szolnok
Vital-Medicina Kft.
NA, Jozsef Attila Utca 17, 8200, Veszprem
Budai Irgalmasrendi Korhaz Nonprofit Kft.
NA, Frankel Leo Ut 17-19, Kerulet, Budapest
Saldinvest Kft.
NA, Seregelyesi Ut 92, 8000, Szekesfehervar
Careggi University Hospital
NA, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Delle Marche
NA, Via Conca 71, 60126, Ancona
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
NA, Piazza Cardinale Andrea Ferrari 1, 20122, Milan
Unidade Local De Saude Do Alto Minho E.P.E.
NA, Largo Conde De Bertiandos, 4990-041, Ponte De Lima
Hospital Garcia De Orta E.P.E.
NA, Avenida Torrado Da Silva, 2801-951, Almada
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
NA, Avenida Professor Egas Moniz, 1649-035, Lisbon
Saint Maria Hospital
NA, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Spitalul Judetean De Urgenta Bacau
NA, Strada Haret Spiru 2-4, 600114, Bacau
Saint Maria Hospital
NA, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Hospital Marina Baixa De La Vila Joiosa
NA, Avenida Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa
Hospital Universitario Y Politecnico La Fe
NA, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario De Santiago
NA, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| Belgium | 2023-12-07 | 2025-09-18 | 2024-04-10 | 2025-05-02 | |
| Bulgaria | 2023-11-09 | 2023-11-16 | 2025-05-02 | ||
| Croatia | 2023-11-28 | 2025-02-04 | 2025-05-02 | ||
| France | 2023-11-13 | 2026-03-05 | 2024-04-08 | 2025-05-02 | |
| Germany | 2023-12-13 | 2024-01-17 | 2025-05-02 | ||
| Greece | 2023-12-18 | 2024-03-04 | 2025-05-02 | ||
| Hungary | 2023-11-07 | 2026-04-29 | 2023-12-12 | 2025-05-02 | |
| Italy | 2024-02-29 | 2025-09-01 | 2024-08-08 | 2025-05-02 | |
| Portugal | 2023-11-27 | 2024-03-27 | 2025-05-02 | ||
| Romania | 2024-01-11 | 2024-05-14 | 2025-05-02 | ||
| Spain | 2023-11-07 | 2026-05-05 | 2023-11-09 | 2025-05-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 100 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | m23700-protocol public Redacted | 3.1 (eu) |
| Protocol (for publication) | m23700-protocol-translated_GR public Redacted | 3.1 (eu) |
| Recruitment arrangements (for publication) | M23-700 Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 BG Doctor to Patient Email_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 BG Doctor to Patient Letter_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 BG Participant Study Guide_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 BG Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 BG Recruitment Brochure_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 DE Doctor to Patient Email_Public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 DE Doctor to Patient Letter_Public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 DE Participant Study Guide_Public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 DE Recruitment Brochure_Public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 Doctor to Patient Email_Dutch_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 Doctor to Patient Email_French_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 Doctor to Patient Letter_Dutch_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 Doctor to Patient Letter_French_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 FR Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | M23-700 FR_Participant Study Guide_Public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 GR Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 HR Doctor to Patient Email_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 HR Doctor to Patient Letter_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 HR Participant Study Guide_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 HR Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 HR Recruitment Brochure_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 IT Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 Participant Study Guide_Dutch_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 Participant Study Guide_French_public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 PT Doctor to Patient Letter_Portuguese_public | 1 |
| Recruitment arrangements (for publication) | M23-700 PT Participant Study Guide Portuguese public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 PT Recruitment and ICFProcedures | 2 |
| Recruitment arrangements (for publication) | M23-700 PT Recruitment Brochure_Portuguese_public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment Brochure_Dutch_public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 Recruitment Brochure_French_public | 1.1 |
| Recruitment arrangements (for publication) | M23-700 RO Participant Study Guide Romanian Public | 1.0 |
| Recruitment arrangements (for publication) | M23-700 RO Recruitment brochure Romanian Public | 1.0 |
| Recruitment arrangements (for publication) | M23-700_Doctor to Patient Email_ITA - Public only | 1 |
| Recruitment arrangements (for publication) | M23-700_Doctor to Patient Letter_ITA- Public only | 1 |
| Recruitment arrangements (for publication) | M23-700_ES_Participant Study Guide_Spanish_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_ES_Recruitment Brochure_Spanish_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_FR_Doctor to Patient Email_Public | 1.1 |
| Recruitment arrangements (for publication) | M23-700_FR_Doctor to Patient Letter_Public | 1.1 |
| Recruitment arrangements (for publication) | M23-700_FR_Recruitment Brochure_Public | 1.1 |
| Recruitment arrangements (for publication) | M23-700_HU_Doctor to Patient Email_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_HU_Doctor to Patient Letter_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_HU_Participant Study Guide_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_HU_Recruitment Brochure_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | M23-700_Participant Study ITA - Public only | 1 |
| Recruitment arrangements (for publication) | M23-700_Recruitment Brochure_ITA - Public only | 1 |
| Subject information and informed consent form (for publication) | L1 M23-700 BE Main ICF Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-700 BE Main ICF English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-700 BE Main ICF French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-700 DE Main ICF German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M23-700 FR Main ICF French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M23-700 GR ICF Main_Public | 4 |
| Subject information and informed consent form (for publication) | L1 M23-700 IT ICF Main_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M23-700 BG ICF Main Bulgarian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-700 BG ICF Main English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-700 ES ICF Optional Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-700 ES Main ICF Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-700 GR ICF Optional_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-700 HU ICF PIS Main Hungarian_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-700_ PT_ICF Main and Optional_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_M23-700_HR_ICF Main_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M23-700_HR_ICF Optional_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M23-700_HR_ICF Pregnant Subject_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M23-700_RO_ICF Main Combined English_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M23-700_RO_ICF Main Combined Romanian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M23-700_RO_ICF Preg Partner English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-700_RO_ICF Preg Partner Romanian_Public | 4.0 |
| Subject information and informed consent form (for publication) | M23-700 BE ICF Optional_Public | 1 |
| Subject information and informed consent form (for publication) | M23-700 BE ICF Optional_Public | 1 |
| Subject information and informed consent form (for publication) | M23-700 BE ICF Optional_Public | 1 |
| Subject information and informed consent form (for publication) | M23-700 GR ICF Preg Part_Public Redacted | 1 |
| Subject information and informed consent form (for publication) | M23-700 HU ICF Optional Genetic Hungarian | 1.1 |
| Subject information and informed consent form (for publication) | M23-700 HU ICF PIS Pregnant Partner Hungarian | 1.1 |
| Subject information and informed consent form (for publication) | M23-700 HU PIS Optional Genetic Hungarian | 1.1 |
| Subject information and informed consent form (for publication) | M23-700 IT ICF Pregant subject_Public | 08Sep23 |
| Subject information and informed consent form (for publication) | M23-700 PT ICF Optional_Public | 2 |
| Subject information and informed consent form (for publication) | M23-700 PT ICF Preg Part_Public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-[Humira] | 2 |
| Synopsis of the protocol (for publication) | M23-700 BE Protocol synopsis - Global - Dutch - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 BE Protocol synopsis - Global - French - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 BE Protocol synopsis - Global - German - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 BG Protocol synopsis -Global-Bulgarian - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 ES Protocol Synopsis - Global - Spanish - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 FR Protocol Synopsis - Global - French - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 GR Protocol Synopsis - Global - Greece - Public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 HU Protocol Synopsis - Global - Hungarian - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 IT Protocol Synopsis - Global - Italian - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700 RO Protocol Synopsis - Global - Romania - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | M23-700-protocol synopsis_PT-PT_Public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | m23700-protocol-synopsis - public | 3.1 (eu) |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M23-700 Lay Version BE Dutch | 2 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M23-700 Lay Version BE French | 2 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M23-700 Lay Version BE German | 2 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M23-700 Lay Version English | 2 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-22 | Italy | Acceptable 2023-10-16
|
2023-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-30 | Italy | Acceptable 2024-05-06
|
2024-05-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-21 | Acceptable | 2024-08-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-22 | Italy | Acceptable 2025-03-17
|
2025-03-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-05-05 | Acceptable | 2025-06-09 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-05-05 | 2025-06-23 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-05-05 | Acceptable | 2025-05-19 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-05-05 | Italy | Acceptable | 2025-06-12 |
| 9 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-05-05 | Acceptable | 2025-06-12 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-05-05 | Acceptable | 2025-06-16 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-05-05 | Acceptable | 2025-05-26 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-05-05 | Acceptable | 2025-06-23 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-05-05 | Acceptable | 2025-07-21 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-23 | 2025-05-05 | Acceptable | 2025-07-17 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-24 | 2025-05-05 | Acceptable | 2025-06-03 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-07-22 | Italy | Acceptable | 2025-09-16 |
| 17 | SUBSTANTIAL MODIFICATION | SM-26 | 2026-01-23 | Acceptable 2026-04-28
|
2026-04-29 |