Clinical trial • Phase III • Musculoskeletal

Clinical trial in Rheumatoid arthritis

Phase III trial for Rheumatoid arthritis. 75 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
28-04-2025
First CTIS Authorization Date
20-08-2025

Trial design

Phase III trial across 16 sites in Germany, Spain, Poland.

Target Sample Size
75
Trial Duration For Participant
532

Eligibility

Recruits 75 Vulnerable population not selected; no consent or assent handling described..

Vulnerable Population
Vulnerable population not selected; no consent or assent handling described.

Recruitment

Planned Sample Size
75
Recruitment Window Months
17

Geography

Total Number Of Sites
16
Total Number Of Participants
39

Germany

Earliest CTIS Part Ii Submission Date
22-07-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
29
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
University Hospital Cologne AöR
Department Name
Med. Klinik 1 für Innere Medizin
Contact Person Name
Philipp Köhler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Krankenhaus Porz Am Rhein gGmbH
Department Name
Klinik für Rheumatologie
Contact Person Name
Johannes Strunk
Contact Person Email
j.strunk@khporz.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentrum II
Contact Person Name
Andrea Everding
Contact Person Email
studienzentrum@hotmail.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Med. Klinik III
Contact Person Name
Valentin Schäfer
Contact Person Email
valentin.schaefer@uk-bonn.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik & Poliklinik IV
Contact Person Name
Hendrik Schulze-Koops

Spain

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
24
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Contact Person Name
María García Manrique
Site Name
Area Sanitaria Da Coruna E Cee
Department Name
Rheumatology
Contact Person Name
Francisco Javier Blanco García
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Rheumatology
Contact Person Name
Juan Miguel Sánchez Bursón
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Rheumatology
Contact Person Name
Francisco Javier Bachiller Corral
Contact Person Email
fbachiller@salud.madrid.org
Site Name
Hospital Del Mar
Department Name
Rheumatology
Contact Person Name
Carolina Pérez García
Contact Person Email
cperezg@parcdesalutmar.cat

Poland

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
22-08-2025
Processing Time Days
30
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Warszawa Targówek - site
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
Clinicmed Daniluk Nowak Sp. k.
Contact Person Name
Stefan Daniluk
Contact Person Email
daniluk@clinicmed.pl
Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Łódź - site
Contact Person Name
Katarzyna Bartnicka-Masłowska
Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Wroclaw - site
Contact Person Name
Ewa Krecipro-Nizińska
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Sławomir Jeka
Contact Person Email
s.jeka@wp.pl
Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Gdynia - site
Contact Person Name
Barbara Grabowicz-Waśko

Sponsor

Primary sponsor

Full Name
Gilead Sciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

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