Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

Exclusion Criteria

• •Receipt of any of the following for at least a 1 month stabilization period prior to dosing: sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
• •Receipt of etanercept for at least a 6 week period prior to dosing
• •Receipt of cyclosporine, infliximab or adalimumab for at least a 2 month period prior to dosing
• •Receipt of leflunomide for at least a 2 month period prior to screening, unless patient has undergone cholestyramine washout at least 1 month prior to dosing
• •Receipt of cyclophosphamide for at least a 6 month period prior to dosing
• •Receipt of rituximab at any previous time
• •Participation in a previous trial CF101 trial
• •Use of oral corticosteroids \>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