Status:
COMPLETED
Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients
Lead Sponsor:
Can-Fite BioPharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 i...
Detailed Description
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00280917
Start Date
June 1 2006
End Date
April 1 2007
Last Update
September 18 2023
Active Locations (35)
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1
Can-Fite Investigational Site
Peoria, Arizona, United States, 85381
2
Can-Fite Investigational Site
Albany, New York, United States, 12206
3
Can-Fite Invesitigational Site
Cleveland, Ohio, United States, 44195
4
Can-Fite Investigational Site
Perrysburg, Ohio, United States, 43551