Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis Disease duration of at least 6 months Must be treated with Methotrexate for at least 24 weeks At least 6 swollen joints and 6 tender joints Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs) Women of childbearing age and all males must use acceptable method of birth control Exclusion Criteria: Tuberculosis Malignancies Abnormal electrocardiograms as described in the protocol Current infection or recurrent infections or immunodeficiency Liver diseases and abnormalities in liver function tests as described in the protocol Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA; History of demyelization diseases Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
25 mg PG-760564
100 mg PG-760564
Placebo, oral dose, BID
25 mg BID, of oral PG-760564
100 mg BID, of oral PG-760564