Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

Inclusion Criteria

• Males and females ages 18-75 years
• Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324; refer to Appendix 1. diagnostic criteria for Rheumatoid Arthritis)
• Not bed- or wheelchair-bound
• Active RA, as indicated by the presence of (a) >=6 swollen joints (28 joint count); AND (b) >=6 tender joints (28 joint count); AND either: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
• Treatment with weekly oral or parenteral methotrexate for >=6 months prior to baseline
• Methotrexate route of administration has been unchanged for >=2 months prior to baseline
• Dose of methotrexate has been stable at 15-25 mg/week for >=2 months, and is expected to remain stable throughout the study; the stable dose of methotrexate may alternatively be 10-12.5 mg/week if documented toxicity has precluded a higher dose
• If taking hydroxychloroquine or chloroquine, administration duration has been for >=3 months and dose has been stable for >=2 months prior to baseline
• If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to baseline, and will remain unchanged during protocol participation
• If taking an oral corticosteroid, dose is 10 mg of prednisone, or equivalent, per day
• Change in NSAID dose level for 1 month prior to dosing
• Change in oral corticosteroid dose level during the 1 month prior to, or during, the stabilization period vChange in hydroxychloroquine or chloroquine dose level during the 2 months prior to, or during, the stabilization period
• Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to, or during, the stabilization period
• Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)
• Hemoglobin level <9.0 gm/dL at the screening visit
• Platelet count <125, 000/mm3 at the screening visit
• White blood cell count <3000/mm3 at the screening visit
• Serum creatinine level outside the central laboratory's normal limits at the screening visit
• Liver aminotransferase (ALT and/or AST) levels greater than 1.25 times the central laboratory's upper limit of normal at the screening visit
• Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study