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

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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
We found this trial at
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Clarksburg, West Virginia 26301
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San Francisco, California 94133
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Westlake Village, California 91361
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Westlake Village, CA
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