A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)

Summary

The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of this study is that among participants with active RA, MK-8457 100 mg twice daily (BID) + MTX will be superior to placebo + MTX as measured by the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) after 12 weeks of treatment.

Timeline

Start

2012-08-29

Primary completion

2013-10-08

Completion

2013-10-08

Outcome

Missed primary endpoint

registry analysis (unspecified test); Base Study: MK-8457 vs Base Study: Placebo; p = 0.308; Difference in least squares means -0.52 (95% CI -1.54 to 0.50); NCT01651936 ↗

Drugs

Indications