MK8457-010 In Rheumatoid Arthritis After Failed Anti-TNF-α Therapy
Research type
Research Study
Full title
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy
IRAS ID
111602
Contact name
Mark Quinn
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2012-002181-12
Clinicaltrials.gov Identifier
Research summary
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder which over time, leads to progressive disability, poor physical function, and reduction in the quality of life. The purpose of this study is to assess the safety and efficacy of MK-8457 in participants with active RA and an inadequate response or intolerance to anti-TNF-a?therapy. This is a Phase IIa, double-blind, placebo-controlled, parallel-group, multi-center worldwide study to assess the safety, tolerability, and efficacy of MK-8457 in participants with active RA and inadequate response or intolerance to anti-TNF-a?treatment. Participants must have either failed treatment with 1 or 2 anti-TNF-a?therapies or are intolerant to anti-TNF-a therapy prior to screening of the study. For participants who have failed therapy, the subjects must have been treated for at least 3 months with anti-TNF-a?therapies. The study design is in two parts; a base study and an extension study. In the base study, approximately 178 subjects will be randomized to treatment with MK-8457 100 mg BID (twice daily) or placebo for a total of 24 weeks. Participants are required to be on background methotrexate (MTX) therapy at stable doses prior to and during the study. Participants in the base study will be eligible for early escape into the extension phase at Week 12 or any point after, if they demonstrate a less than 20% improvement in both tender and swollen joint counts. After the base study, participants may choose to continue into the safety extension portion of the study and receive MK-8457 100 mg BID for up to a total of 100 weeks of treatment or choose to either withdraw from the study.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0642
Date of REC Opinion
12 Nov 2012
REC opinion
Further Information Favourable Opinion