Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Can-Fite BioPharma
• Treatments: Methotrexate

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