A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
Status: Recruiting
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
• Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
• Has current treatment with oral or parenteral methotrexate (MTX) therapy
• Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS
Locations
United States
Arizona
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
RECRUITING
Glendale
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
RECRUITING
Mesa
California
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
RECRUITING
La Palma
Colorado
Tekton Research, LLC. ( Site 1008)
RECRUITING
Fort Collins
Florida
Sweet Hope Research Specialty, Inc ( Site 1015)
RECRUITING
Hialeah
HMD Research LLC ( Site 1016)
RECRUITING
Orlando
Illinois
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
RECRUITING
Orland Park
Michigan
AA Medical Research Center ( Site 1027)
RECRUITING
Grand Blanc
Missouri
Kansas City Physician Partners ( Site 1032)
RECRUITING
Kansas City
Nebraska
Physician Research Collaboration, LLC ( Site 1002)
RECRUITING
Lincoln
Pennsylvania
altoona center for clinical research ( Site 1005)
RECRUITING
Duncansville
Rheumatology Specialty Center ( Site 1030)
RECRUITING
Willow Grove
Tennessee
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)
RECRUITING
Murfreesboro
Texas
Rheumatology Associates ( Site 1026)
RECRUITING
Arlington
Epic Medical Research ( Site 1004)
RECRUITING
Red Oak
Advanced Rheumatology of Houston - Woodlands ( Site 1000)
RECRUITING
The Woodlands
Other Locations
Canada
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)
RECRUITING
Sherbrooke
Centre de Recherche Musculo-Squelettique ( Site 1101)
RECRUITING
Trois-rivières
Chile
CECIM ( Site 1208)
RECRUITING
Santiago
Centro de Estudios GyC ( Site 1206)
RECRUITING
Santiago
Clinica Dermacross ( Site 1203)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)
RECRUITING
Santiago
China
Peking University First Hospital ( Site 2511)
RECRUITING
Beijing
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)
RECRUITING
Guangzhou
Linfen Central Hospital ( Site 2507)
RECRUITING
Linfen
Taizhou Hospital of Zhejiang Province ( Site 2506)
RECRUITING
Linhai
Pingxiang People's Hospital ( Site 2512)
RECRUITING
Pingxiang
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)
RECRUITING
Ürümqi
The First Affiliated Hospital of Xiamen University. ( Site 2510)
RECRUITING
Xiamen
Xinxiang Central Hospital ( Site 2501)
RECRUITING
Xinxiang
Colombia
Clinica de la Costa S.A.S. ( Site 1301)
RECRUITING
Barranquilla
CIREEM SAS ( Site 1304)
RECRUITING
Bogota
Fundación Valle del Lili ( Site 1305)
RECRUITING
Cali
Germany
Rheumatologische Schwerpunktpraxis ( Site 1603)
RECRUITING
Berlin
Rheuma-Research Lausitz ( Site 1604)
RECRUITING
Cottbus
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)
RECRUITING
Hamburg
Medicover München Ost MVZ ( Site 1607)
RECRUITING
München
Rheumazentrum Ratingen Studienambulanz ( Site 1601)
RECRUITING
Ratingen
Japan
University of Yamanashi Hospital ( Site 2603)
RECRUITING
Chūō
Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)
RECRUITING
Hanishina-gun
Kai Clinic ( Site 2600)
RECRUITING
Miyazaki
Nagaoka Red Cross Hospital ( Site 2604)
RECRUITING
Nagaoka
Sasebo Chuo Hospital ( Site 2602)
RECRUITING
Sasebo
Hirose Clinic ( Site 2601)
RECRUITING
Tokorozawa
Poland
MICS Centrum Medyczne Bydgoszcz ( Site 1807)
RECRUITING
Bydgoszcz
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)
RECRUITING
Bydgoszcz
NZOZ BIF-MED ( Site 1802)
RECRUITING
Bytom
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)
RECRUITING
Lublin
MICS Centrum Medyczne Torun ( Site 1803)
RECRUITING
Torun
MICS Centrum Medyczne Warszawa ( Site 1805)
RECRUITING
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)
RECRUITING
Warsaw
Republic of Korea
Soon Chun Hyang University Cheonan Hospital ( Site 2304)
RECRUITING
Cheonan-si
Chungnam national university hospital ( Site 2303)
RECRUITING
Daejeon
Hanyang University Seoul Hospital ( Site 2300)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron ( Site 1901)
RECRUITING
Barcelona
Hospital Universitari Parc Tauli ( Site 1900)
RECRUITING
Sabadell
Hospital Universitario Marqués de Valdecilla ( Site 1906)
RECRUITING
Santander
Hospital Clinico Universitario de Santiago ( Site 1903)
RECRUITING
Santiago De Compostela
United Kingdom
The Princess Alexandra Hospital NHS Trust ( Site 2103)
RECRUITING
Harlow
Chapel Allerton Hospital ( Site 2106)
RECRUITING
Leeds
Barnet Hospital ( Site 2102)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2029-09-03
Participants
Target number of participants: 182
Treatments
Experimental: High-dose tulisokibart
Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
Experimental: Medium-dose tulisokibart
Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.
Experimental: Low-dose tulisokibart
Participants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.
Placebo_comparator: Placebo
Participants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC