A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study Evaluating Tulisokibart for Rheumatoid Arthritis

What this Trial Is About

Researchers are investigating new ways to treat rheumatoid arthritis RA, especially for people whose symptoms do not respond well to standard treatments like methotrexate MTX. This study aims to evaluate a medicine called tulisokibart to see if it can reduce active RA symptoms better than a placebo. The study focuses on different doses of tulisokibart to determine which dose might be most effective while participants continue their MTX treatment. Participants will be randomly assigned to receive one of several treatments MTX plus a high, medium, or low dose of tulisokibart, or MTX plus a placebo that looks like tulisokibart but contains no active medicine. Those on the low dose or placebo will be re-randomized at week 12 to either a medium or high dose of tulisokibart. The study includes a 12-week placebo-controlled period followed by a long-term extension lasting 116 weeks, split into a 44-week main extension and a 72-week optional extension. During the study, participants will have their RA symptoms and response to treatment assessed using criteria such as the American College of Rheumatology 20 response at week 12. Researchers will also monitor safety by recording adverse events and treatment discontinuations up to about week 142. The study involves regular evaluations, including questionnaires and clinical assessments, to track disease activity, physical function, and overall health over the entire study period.

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)