Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
2,167
Countries
15
Sites
102
Rheumatoid Arthritis
To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE (Venous Thromboembolism)
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 25 Jul 2019 → 29 May 2025
- Decision date (initial)
- 2024-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508022-10-00
- EudraCT number
- 2018-003351-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE (Venous Thromboembolism)
Conditions and MedDRA coding
Rheumatoid Arthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must have at least one of the following characteristics: documented evidence of a VTE prior to this study, At least 60 years of age, A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²) ,Or age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
- Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Exclusion criteria 8
- Participant should have no reason to not take a TNF inhibitor.
- Participants must not be pregnant or breastfeeding.
- Participants must not have had more than one VTE.
- Participants must not have cancer.
- Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
- Participants must not have had a live vaccine within four weeks of study start.
- Participants must not have participated in any other clinical trial within four weeks of study start.
- Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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
- 8031 mg milligram(s)
- Max treatment duration
- 66 Month(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 as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
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
- 8031 mg milligram(s)
- Max treatment duration
- 66 Month(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 as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
Comparator 3
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 31680 mg milligram(s)
- Max treatment duration
- 66 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 31680 mg milligram(s)
- Max treatment duration
- 66 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01984MIG · Substance
- Active substance
- Etanercept
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 14289 mg milligram(s)
- Max treatment duration
- 66 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 9
| Organisation | City, country | Duties |
|---|---|---|
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Fortrea Inc. ORG-100012602
|
Princeton, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other, Code 5 |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Data management |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
Locations
15 EU/EEA countries · 102 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 8 | 2 |
| Belgium | Ended | 20 | 3 |
| Czechia | Ended | 346 | 13 |
| Denmark | Ended | 4 | 3 |
| France | Ended | 16 | 6 |
| Germany | Ended | 74 | 8 |
| Greece | Ended | 17 | 3 |
| Hungary | Ended | 117 | 5 |
| Italy | Ended | 24 | 4 |
| Lithuania | Ended | 15 | 3 |
| Netherlands | Ended | 13 | 2 |
| Poland | Ended | 416 | 18 |
| Romania | Ended | 118 | 9 |
| Slovakia | Ended | 48 | 6 |
| Spain | Ended | 183 | 17 |
| Rest of world
South Africa, Switzerland, Russian Federation, Australia, United Kingdom, Israel, United States
|
— | 748 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
5th Medical Department with Endocrinology, Rheumatology and Acute Geriatrics, Montleartstrasse 37, Ottakring, Vienna
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Internal Medicine III, Division of Rheumatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Hopital Erasme
Rheumatology, Lennikse Baan 808, 1070, Anderlecht
Het Ziekenhuisnetwerk Antwerpen
Rheumatology, Lange Bremstraat 70, 2170, Antwerp
Reumaclinic
Rheumatology, Jaarbeurslaan 21/22, 3600, Genk
Artroscan s.r.o.
N/A, Trebovicka 5114/106, 722 00, Trebovice
Revmatologie s.r.o.
N/A, Halasovo Namesti 597/1, Lesna, Brno-Sever
Affidea Praha s.r.o.
Revmatologie, Sustova 1930/2, Chodov, Prague 11
Revmaclinic s.r.o.
N/A, Zamecnicka 87/1, Brno-Mesto, Brno-Stred
Revmacentrum MUDr. Mostera s.r.o.
N/A, Mosnova 2476/8, Zidenice, Brno-Zidenice
Revmatologicky Ustav
N/A, Na Slupi 450/4, Nove Mesto, Prague 2
Inrea s.r.o.
Interni a revmatologicka ambulance, Ruska 99/44, Vitkovice, Ostrava
Arthrohelp s.r.o.
N/A, Rokycanova 2798, Zelene Predmesti, Pardubice
PV-Medical s.r.o.
Revmatologicka ambulance, Stefanikova 477, 760 01, Zlin
MuDr. Zuzana Urbanova
Revmatologicka ambulance, Petra Rezka 1090/3, Nusle, Prague 4
Medical Plus s.r.o.
N/A, Obchodni 1507, 686 01, Uherske Hradiste
MuDr. Zuzana Stejfova
Revmatologicka ambulance, Taborska 325/57, Nusle, Prague
Clintrial s.r.o.
N/A, Pocernicka 1427/16, Strasnice, Prague 10
Region Midtjylland
Reumatologisk, Falkevej 1/3, 8600, Silkeborg
Region Midtjylland
Reumatologisk, Hospitalsparken 15, 7400, Herning
Odense University Hospital
Reumatologisk, Baagoees Alle 15, 5700, Svendborg
Pellegrin Hospital
Rhumatologie, Place Amelie Raba Leon, 33000, Bordeaux
Ass Hospitaliere Protestante De Lyon
Rhumatologie, 3 Chemin Du Penthod, 69300, Caluire Et Cuire
Centre Hospitalier Universitaire De Nice
Rhumatologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Regional D'Orleans
Rhumatologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire De Toulouse
Recherche Clinique Rhumatologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
University Hospitals Pitie Salpetriere Charles Foix
Service de Rhumatologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Rheumazentrum Ratingen
N/A, Calor-Emag-Strasse 3, 40878, Ratingen
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
N/A, Goethestrasse 40, 18209, Bad Doberan
University Hospital Cologne AöR
Rheumatologie und Klinische Immunologie, Kerpener Strasse 62, Lindenthal, Cologne
Goethe University Frankfurt
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Rheumapraxis Hamburg
Hamburger Rheuma-Forschungszentrum I / HRFI, Kritenbarg 7, 22391, Hamburg
Schlosspark-Klinik GmbH
Innere Medizin II, Rheumatologie, Heubnerweg 2, Charlottenburg, Berlin
Institut Fuer Praeventive Medizin & Klinische Forschung GbR
N/A, Johannes-Schlaf-Strasse 35, Stadtfeld West, Magdeburg
University General Hospital Of Alexandroupoli
1st Department of Internal Medicine, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Ippokratio General Hospital Of Thessaloniki
4th Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Attikon
4th Department of Medicine, Rimini Street 1, 124 62, Athens
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
CRU Hungary Kft.
N/A, Petofi Ut 26a, 3860, Encs
Vital-Medicina Kft.
Vital Medical Center, Jozsef Attila Utca 17, 8200, Veszprem
Revita Kft.
N/A, Margit Korut 50-52 Fszt. 9, Kerulet, Budapest II
University Of Debrecen
Belgyogyaszati Klinika (Reumatologiai Tanszek), Moricz Zsigmond Korut 22, 4032, Debrecen
Universita' Degli Studi G. D'annunzio Di Chieti
Medicina Interna, Via Dei Vestini 31, 66100, Chieti
Universita' Degli Studi Di Verona
Reumatologia, Strada Le Grazie 8, 37134, Verona
Careggi University Hospital
Medicina Interna, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Reumatologia, Via Sergio Pansini 5, 80131, Naples
Republican Kaunas Hospital, Public Institution
Rheumatology, Hipodromo str. 13, LT-45130, Kaunas
Republican Siauliai Hospital, Public Institution
Rheumatology, V. Kudirkos str. 99, LT-76231, Siauliai
Center Outpatient Clinic, Public Institution
Rheumatology, Pylimo str. 3, LT-01117, Vilnius
PreCare Trial & Recruitment B.V.
Rheumatology, Elsstraat 47, 6191 JW, Beek Lb
Medisch Centrum Leeuwarden B.V.
Rheumatology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Samodzielny Publiczny Zespół Opieki Zdrowotnej w Tomaszowie Lubelskim
N/A, Aleje Grunwaldzkie 1, 22-600, Tomaszow Lubelski
Ai Centrum Medyczne Sp. z o.o. S.K.
No Department, Ul. Swietojanska 1, 61-113, Poznan
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
No Department, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Rheuma Medicus Sp. z o.o.
No Department, Ul. Pruszkowska 6, 02-118, Warsaw
Klinika Reuma Park Sp. z o.o. S.K.
No Department, Aleja Wilanowska 333, 02-665, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
No Department, Ul. Na Zaspe 3, 80-546, Gdansk
Medicover Integrated Clinical Services Sp. z o.o.
No Department, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Sląskie Centrum Reumatologii Ortopedii I Rehabilitacji W Ustroniu Sp. z o.o.
No Department, Ul. Szpitalna 11, 43-450, Ustron
NZOZ Lecznica Mak Med s.c.
No Department, Ul. Wisniowa 22, 05-830, Nadarzyn
Medicover Integrated Clinical Services Sp. z o.o.
No Department, Ul. Stefana Batorego 18/22, 87-100, Torun
Bif-Med
No Department, ul. Zeromskiego 18, 41-902, Bytom
Pratia S.A.
No Department, Ul. Dabrowki 13, 40-081, Katowice
Osteo-Medic sc A. Racewicz, J. Supronik
No Department, ul. Wiejska 81, 15-351, Bialystok
Etg Warszawa Sp. z o.o.
No Department, Ul. Wynalazek 4, 02-677, Warsaw
Centrum Medyczne Amed Sp. z o.o.
No, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Ambulatorium Sp. z o.o.
No Department, Ul. Topolowa 28, 82-300, Elblag
Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł Hrycaj
No Department, Os. Rzeczypospolitej 6/202, 61-397, Poznań
Delta Health Care S.R.L.
Rheumatology, Str Nicolae Caramfil Nr 85a Sector 1, 014146, Bucharest
Medaudio-Optica S.R.L.
Rheumatology, Calea Calea Lui Traian Nr 269, 240636, Ramnicu Valcea
Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati
Rheumatology, Strada Brailei 177, 800578, Galati
Saint Maria Hospital
Rheumatology, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Cmi Cristei Dorica
Rheumatology, Blvd INDEPENDENTEI NO 2,, 810019, Braila
Saint Maria Hospital
Rheumatology, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Clinical Studies, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
Rheumatology, Strada Cosbuc George Nr 31, 430031, Baia Mare
Policlinica CCBR S.R.L.
Rheumatology, Aleea Buchetului 2 Block C2 Sector 3, 030463, Bucharest
Leram s.r.o.
Reumatologická ambulancia, Bernolakova 2476/34, 955 01, Topolcany
Albamed s.r.o.
Reumatologická ambulancia, Kuzmanyho Nabrezie 12, 960 01, Zvolen
Romjan s.r.o.
Reumatologická ambulancia, Udernicka 1, 851 01, Petrzalka
Artromac N.O.
Reumatologická ambulancia, Toryska 275/1, Zapad, Kosice
REUMACENTRUM s.r.o.
Reumatologická ambulancia, Hrncirikova 194/5, 958 01, Partizanske
REUMED s.r.o.
Reumatologická ambulancia, Jánskeho 1, 05201, Spišská Nová Ves
Hospital Quironsalud Barcelona
Rheumatology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Complexo Hospitalario Universitario De Santiago
Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De Fuenlabrada
Rheumatology, Camino Del Molino 2, 28942, Fuenlabrada
Hospital de Sant Joan Despi Moises Broggi
Rheumatology, Calle Jacint Verdaguer 90, 08970, Sant Joan Despi
Hospital Universitario Virgen De La Macarena
Rheumatology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Basurto
Rheumatology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Marina Baixa De La Vila Joiosa
Rheumatology, Avenida Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa
Hospital Universitario De Getafe
Rheumatology, Carretera De Madrid Toledo Km 12,500, 28905, Getafe
Complexo Hospitalario Universitario A Coruna
Rheumatology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario La Paz
Rheumatology, Paseo Castellana 261, 28046, Madrid
Clinica Gaias Santiago
Rheumatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Parc Tauli Hospital Universitari
Rheumatology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Clinic De Barcelona
Rheumatology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Rheumatology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Sagrada Familia
Rheumatology, Calle Torras i Pujalt 1, 08022, Barcelona
Complexo Hospitalario Universitario De Vigo
Rheumatology, Estrada Clara Campoamor N 341, 36312, Vigo
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 | 2019-07-25 | 2019-10-30 | 2020-11-09 | ||
| Belgium | 2019-10-08 | 2019-10-14 | 2020-11-09 | ||
| Czechia | 2019-09-10 | 2019-09-16 | 2020-11-09 | ||
| Denmark | 2020-03-18 | 2020-09-09 | 2020-11-09 | ||
| France | 2019-11-14 | 2020-02-12 | 2020-11-09 | ||
| Germany | 2019-08-28 | 2019-09-05 | 2020-11-09 | ||
| Greece | 2019-11-20 | 2020-01-15 | 2020-11-09 | ||
| Hungary | 2019-11-13 | 2019-11-18 | 2020-11-09 | ||
| Italy | 2019-09-24 | 2019-10-03 | 2020-11-09 | ||
| Lithuania | 2020-07-02 | 2020-07-02 | 2020-11-09 | ||
| Netherlands | 2019-09-13 | 2020-01-21 | 2020-11-09 | ||
| Poland | 2019-09-10 | 2019-09-11 | 2020-11-09 | ||
| Romania | 2019-10-17 | 2019-10-27 | 2020-11-09 | ||
| Slovakia | 2020-01-14 | 2020-01-27 | 2020-11-09 | ||
| Spain | 2019-09-12 | 2019-09-16 | 2020-11-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| I4V-MC-JAJA EU-CTIS summary of results SUM-136085
|
2026-05-27T10:35:31 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| I4V-MC-JAJA lay person summary of results | 2026-05-27T10:35:52 | Submitted | Laypersons Summary of Results |
Documents 159 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | I4V-MC-JAJA lay person summary of results | 1 |
| Protocol (for publication) | D1_Protocol 2023-508022-10-00_Redacted | f |
| Protocol (for publication) | D1_Protocol_2023-508022-10-00_GR_Redacted | f |
| Protocol (for publication) | D4_Patien facing document_Slate_eCOA_RU_san | 1 |
| Protocol (for publication) | Patient Documents Copyright Template | 2 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment Arrangement Blank_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_List of participating sites and investigators_FR_Redacted | 7 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement and ICF procedure declaration_san | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Blank statement | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_GR | 1 |
| Recruitment arrangements (for publication) | K2_Poster_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appreciation Program Overview_IRB 103019 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of participating sites_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Diary_V1_paper_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ThankYouCards_M_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_VTE Patient Reminder_V1_paper_RO_1_ | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF NLD_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_Country_Specific_ICF_RO_Romanian_JAJA_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_GP Letter_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_FR_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF Summary of Changes for subjects_Clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Summary of Changes for subjects_Tracked Changes | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_DTP_GR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC1_Main | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Summary_of_Changes_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Summary of Changes_22 Jul 2024_RO | 2 |
| Subject information and informed consent form (for publication) | L1_JAJA_Germany_COVID19 - Addendum ICF_DTP | 1 |
| Subject information and informed consent form (for publication) | L1_JAJA_Germany_COVID19 - Addendum ICF_visits | 1 |
| Subject information and informed consent form (for publication) | L1_JAJA_Germany_Main ICF_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Summary Of Changes_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 6.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SoC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_clean_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_highlighted_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_highlighted_Redacted_02Nov2023 | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_Redacted_02Nov2023 | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_redline_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of changes | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_JAJA_Summary of Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_11Jul2024 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_SK | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Consent | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Consent_BEDU | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Consent_BEFR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes SoC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes SoC_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Tutela dei dati personali_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main SoC_lt_san | V1.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main SoC_ru_san | V1.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main_lt_red | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main_ru_red | 4.0 |
| Subject information and informed consent form (for publication) | L1-SIS-ICF_ICF Main_ JAJA v6.1_DK_Clean | 6.1 |
| Subject information and informed consent form (for publication) | L2_ancillary items | 1 |
| Subject information and informed consent form (for publication) | L2_Ancillary items list_FR | 1 |
| Subject information and informed consent form (for publication) | L2_ApptReminderCardPrint_GR | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Appreciation Program_IRB_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Appreciation Program_Site_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card JAJA - Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Program Overview | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardElectronic | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardElectronic | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardElectronic | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardPrint | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardPrint | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCardPrint | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency cards | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly_Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MEMO_Appreciation Program Overview | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Diary_Paper | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient information card | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Appreciation Program Outline | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Retention Program Summary_Site | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_General | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ThankYouCards | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ThankYouCards | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VisitGuide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTE Patient Reminder | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTE Patient Reminder | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTE Patient Reminder | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTE Patient Reminder_Paper_Slovak | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTEBrochure | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTEBrochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VTEBrochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient information card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_VisitGuide_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Contact Card_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Emergency Card_RO | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Summary of Changes BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Summary of Changes BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Summary of Changes EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_JAJA | 2 |
| Subject information and informed consent form (for publication) | L2_ThankYouCard_GR | 1 |
| Subject information and informed consent form (for publication) | L2_VisitGuide_GR_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_VTE Patient Reminder_GR | 1 |
| Subject information and informed consent form (for publication) | L2_VTE_FR | 1 |
| Subject information and informed consent form (for publication) | L2_VTEBrochure_GR | 1 |
| Subject information and informed consent form (for publication) | L3_Besuchsterminplan_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Dankeskarte | 1 |
| Subject information and informed consent form (for publication) | L3_I4V-MC-JAJA_VTE Merkblatt | 1 |
| Subject information and informed consent form (for publication) | L3_Information uber die Studie | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card | 2 |
| Subject information and informed consent form (for publication) | L3_Terminerinnerungen | 1 |
| Subject information and informed consent form (for publication) | L3_VTE Information | 1 |
| Subject information and informed consent form (for publication) | L3_Willkommensbrief_Redacted | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amgevita | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC baricitinib | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Enbrel | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Humira | 1.0 |
| Summary of results (for publication) | I4V-MC-JAJA EU-CTIS summary of results | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis TC_FR_2023-508022-10-00_Redacted | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR_2023-508022-10-00_Redacted | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopis_2023-508022-10-00_GR_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis AUT -DE 2023-508022-10-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10 BEDE_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10 BEDU_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10 BEFR_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10-00_CZ_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10-00_HU_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10-00_lt_redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508022-10-00_SK_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-508022-10-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2023-508022-10-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2023-508022-10-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2023-508022-10-00_TC | e-f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-508022-10-00_Redacted | f |
| Synopsis of the protocol (for publication) | D4_Protocol Synopsis_2023-508022-10-00_SP_Redacted | 1.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-27 | Czechia | Acceptable 2024-01-17
|
2024-01-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-07 | Czechia | Acceptable 2024-11-08
|
2024-11-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-19 | Acceptable 2024-11-08
|
2024-11-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-19 | Acceptable | 2025-01-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-28 | Acceptable | 2025-01-24 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-04 | Czechia | 2025-02-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-19 | Acceptable | 2025-04-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-10 | Acceptable | 2025-04-08 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-13 | Acceptable | 2025-05-13 |