Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Despite MTX Therapy (MK-8457-008 AM6)
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/19/2013 |
Start Date: | May 2012 |
End Date: | September 2017 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate
(MTX) in subjects with active rheumatoid arthritis (RA) despite MTX therapy.
Country-Specific Amendments: Amendments 1, 2, and 4 (Brazil); Amendments 5 and 6 (Japan)
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
HIV infection
- Human immunodeficiency virus 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
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