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Spartanburg, South Carolina 29303


This is a Phase 2, randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week treatment trial of a MEK inhibitor with oral delivery in patients with active RA on stable doses of MTX for ≥6 weeks. Prior biological therapy is not allowed. Other therapies that are currently effective and tolerated should not be discontinued just to participate in this trial. Approximately 200 patients will be enrolled in this study. All patients will be randomized to 1 of 3 dosing regimens of ARRY-438162 (10 mg BID, 40 mg QD, 20 mg BID) or placebo.


Inclusion Criteria: - Provided written informed consent and is willing to comply to scheduled visits, treatment plans, laboratory tests, and other trial procedures. - Has received a stable dose of methotrexate for > 6 weeks prior to screening and is willing to continue on this regimen for duration of study. - Has never received biological agents for the treatment of RA and agree not to do so for duration of study. - Has been diagnosed with RA prior to the screening visit. - Has received a stable dose of folate for > 6 weeks and is willing to continue in this regimen for the duration of the study. - Additional Inclusion Criteria Apply Exclusion Criteria: - Patients with a diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures. - Patients with a history of: severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with RA. - Additional Exclusion Criteria Apply



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Spartanburg, South Carolina 29303
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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