Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

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, Appendix 1)
• 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 >=28mm/hour; OR (d) CRP level above the upper limit of normal for the central referencelaboratory
• Elevated PBMC A3AR expression level, defined as >= 1.5-fold over a predeterminednormal population standard, following the appropriate DMARD/biologic washout period (see Exclusion Criteria) but within 2 weeks of beginning dosing
• If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for atleast 1 month prior to the A3AR Qualification Visit, and will remain unchanged duringprotocol participation
• If taking an oral corticosteroid, dose is <=10 mg/day prednisone or equivalent, hasbeen stable for at least 1 month prior to the A3AR Qualification Visit, and willremain unchanged during protocol participation
• In the Investigator's opinion, the ability to understand the nature of the study andany hazards of participation, and to communicate satisfactorily with the Investigatorand to participate in, and to comply with, the requirements of the entire protocol
• Negative screening serum pregnancy test for female patients of childbearing potential
• Females of childbearing potential must utilize, throughout the course of the trial, 2methods of contraception deemed adequate by the Investigator (for example, oralcontraceptive pills plus a barrier method)
• All aspects of the protocol explained and written informed consent obtained

Exclusion Criteria:

• Receipt of any of the following for at least a 1 month washout period prior to theA3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold,azathioprine, minocycline, penicillamine, anakinra
• Receipt of etanercept for at least a 6 week washout period prior to the A3ARQualification Visit
• Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab oradalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
• Receipt of leflunomide for at least a 2 month washout period prior to the A3ARQualification Visit, unless patient has undergone cholestyramine washout at least 1month prior to testing
• Receipt of cyclophosphamide for at least a 6 month period prior to the A3ARQualification Visit
• Receipt of rituximab at any previous time
• Previous failure to respond to methotrexate or any anti-rheumatic biological agent
• 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 the A3AR Qualification Visit
• Change in oral corticosteroid dose level during the 1 month prior to the A3ARQualification Visit
• Receipt of parenteral or intra-articular corticosteroids during the 1 month prior tothe A3AR Qualification Visit