Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CF101; Placebo control
Intervention description: orally q12h; orally q12 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial will test the hypothesis that the administration of CF101, a novel
      anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at
      baseline will relieve signs and symptoms of the disease.
    

Eligibility criteria:

        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 >=28
             mm/hour; OR (d) CRP level above the upper limit of normal for the central reference
             laboratory

          -  Elevated PBMC A3AR expression level, defined as >= 1.5-fold over a predetermined
             normal 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 at
             least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during
             protocol participation

          -  If taking an oral corticosteroid, dose is <=10 mg/day prednisone or equivalent, has
             been stable for at least 1 month prior to the A3AR Qualification Visit, and will
             remain unchanged during protocol participation

          -  In the Investigator's opinion, the ability to understand the nature of the study and
             any hazards of participation, and to communicate satisfactorily with the Investigator
             and 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, 2
             methods of contraception deemed adequate by the Investigator (for example, oral
             contraceptive 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 the
             A3AR 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 A3AR
             Qualification Visit

          -  Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or
             adalimumab 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 A3AR
             Qualification Visit, unless patient has undergone cholestyramine washout at least 1
             month prior to testing

          -  Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR
             Qualification 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 A3AR
             Qualification Visit

          -  Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to
             the A3AR Qualification Visit