Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CF101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA

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 Rheumatism Association 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 at least one of the following: (c)
             Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for
             the central reference laboratory; OR (e) morning stiffness for >=45 minutes

          -  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, administration duration has been >=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 washout period, and will remain stable
             through the washout and entire treatment and follow-up period

          -  Absence of clinically significant findings, such as interstitial pneumonitis or active
             pulmonary infection, on chest X-ray taken within 6 months prior to screening

        Exclusion Criteria:

          -  Receipt of any of the following for at least a 1 month washout 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

          -  Receipt of CF101 in a previous 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
             washout period

          -  Change in hydroxychloroquine dose level during the 2 months prior to, or during, the
             washout period

          -  Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to,
             or during, the washout period

          -  Presence or history of uncontrolled asthma

          -  Presence or history of uncontrolled arterial hypertension or symptomatic hypotension

          -  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/L

          -  Platelet count <125,000/mm3

          -  White blood cell count <3000/mm3

          -  Serum creatinine level outside the laboratory's normal limits

          -  Liver aminotransferase levels greater than 1.2 times the laboratory's upper limit of
             normal

          -  Known or suspected immunodeficiency or human immunodeficiency virus positivity

          -  Pregnancy, lactation, or inadequate contraception as judged by the Investigator