Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

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) despite MTX therapy. The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment.

Timeline

Start

2012-05-22

Primary completion

2013-10-03

Completion

2013-10-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Base Study Phase IIa: MK-8457 vs Base Study Phase IIa: Placebo; p <0.001; Difference of percentages 43.90 NCT01569152 ↗

Drugs

Indications