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

• Status: Terminated
• Trial end date: 2013-10-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis for at least 6 months prior to screening

• Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66 count) and >= 6 tender joints (of 68 joint count)

• C-reactive protein blood level >0.9 mg/dL

• Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening

• American College of Rheumatology Functional Class I, II, or III

• Received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening

• If using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone

• No history of either untreated, latent, or active tuberculosis prior to baseline

• Participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control

Exclusion Criteria:

• Presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease

• Positive hepatitis B surface antigen or hepatitis C test result or the presence of Human immunodeficiency virus (HIV) infection

• HIV positive

• User of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence

• Females of childbearing potential who are pregnant, intend to become pregnant, or are lactating;

• Severe opportunistic infection within 6 months prior to study start.