Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
114
Countries
3
Sites
15
Rheumatoid Arthritis
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 17 Nov 2025 → ongoing
- Decision date (initial)
- 2025-08-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 13 | 4 |
| Poland | Ongoing, recruiting | 12 | 6 |
| Spain | Ongoing, recruiting | 14 | 5 |
| Rest of world
United States, Moldova, Republic of, Georgia
|
— | 75 | — |
Investigational sites
University Hospital Cologne AöR
Med. Klinik 1 für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Krankenhaus Porz Am Rhein gGmbH
Klinik für Rheumatologie, Urbacher Weg 19, Porz, Cologne
LMU Klinikum Muenchen AöR
Medizinische Klinik & Poliklinik IV, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Futuremeds Sp. z o.o.
FutureMeds Warszawa Targówek - site, Ul. Sw. Wincentego 93 Lok. 5/6/7, 03-291, Warsaw
Futuremeds Sp. z o.o.
FutureMeds Gdynia - site, Ul. Wladyslawa IV 59, 81-384, Gdynia
Futuremeds Sp. z o.o.
FutureMeds Łódź - site, Ul. Gruszowa 2, 91-363, Lodz
Futuremeds Sp. z o.o.
FutureMeds Wroclaw - site, Ul. Legnicka 16, 53-673, Wroclaw
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Toruń, Ul. Stefana Batorego 18-22, 87-100, Torun
Clinicmed Daniluk Nowak Sp. k.
n/a, Ul. Stoleczna 7/200, 15-879, Bialystok
Parc Tauli Hospital Universitari
Rheumatology, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario Ramon Y Cajal
Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Del Mar
Rheumatology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Area Sanitaria Da Coruna E Cee
Rheumatology, Lugar Jubias De Arriba Num 84, 15006, A Coruna
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 |
|---|---|---|---|---|---|
| Germany | 2025-11-17 | 2026-01-07 | |||
| Poland | 2025-11-21 | 2025-12-11 | |||
| Spain | 2025-11-18 | 2026-03-04 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-28 | Germany | Acceptable 2025-08-18
|
2025-08-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-23 | Acceptable | 2025-10-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Germany | Acceptable | 2025-10-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-27 | Germany | Acceptable 2026-05-26
|
2026-05-29 |