Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

• Status: Completed
• Trial end date: 2009-04-01
• 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 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