A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
Merck Sharp & Dohme LLC
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.
Description
This study consists of a 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 72-week Optional Extension
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 Re…
Interventions
- DrugTulisokibart
Subcutaneous (SC) administration
- DrugPlacebo
SC Injection
- DrugMethotrexate
Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.
Locations (62)
- Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)Glendale, Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)Mesa, Arizona
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)La Palma, California
- Tekton Research, LLC. ( Site 1008)Fort Collins, Colorado
- Sweet Hope Research Specialty, Inc ( Site 1015)Hialeah, Florida
- HMD Research LLC ( Site 1016)Orlando, Florida