Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CF101; Placebo
Intervention description: orally q12h; orally q12h
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory
      agent, will improve the clinical condition of patients with rheumatoid arthritis who still
      have active joint inflammation despite taking methotrexate for at least 6 months.
    

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; 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/day prednisone or equivalent, has
             been stable for at least 1 month prior to the stabilization period, and will remain
             stable through the stabilization and entire treatment and follow-up period

          -  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)

        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