Rheumatoid Arthritis Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis
NCT number | NCT00280917 |
Other study ID # | CF101-202RA |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | April 2007 |
Verified date | August 2023 |
Source | Can-Fite BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 254 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Can-Fite Investigational Site | Plovdiv | |
Bulgaria | Can-Fite Investigational Site | Sofia | |
Bulgaria | Can-Fite Investigational Site | Sofia | |
Bulgaria | Can-Fite Investigational Site | Stara Zagora | |
Israel | Can-Fite Investigational Sites | Afula | |
Israel | Can-Fite Investigational Site | Ashkelon | |
Israel | Can-Fite Investigational Site | Beer Yaakov | |
Israel | Can-Fite Investigational Site | Haifa | |
Israel | Can-Fite Investigational Site | Haifa | |
Israel | Can-Fite Investigational Site | Jerusalem | |
Israel | Can-Fite Investigational Site | Jerusalem | |
Israel | Can-Fite Investigational Site | Jerusalem | |
Israel | Can-Fite Investigational Site | Kfar-Saba | |
Israel | Can-Fite Investigational Site | Tel Hashomer | |
Poland | Can-Fite Investigational Site | Bialystok | |
Poland | Can-Fite Investigational Site | Lublin | |
Poland | Can-Fite Investigational Site | Sopot | |
Poland | Can-Fite Investigational Site | Szczecin | |
Romania | Can-Fite Investigational Site | Brasov | |
Romania | Can-Fite Investigational Site | Bucharest | |
Romania | Can-Fite Investigational Site | Bucharest | |
Romania | Can-Fite Investigational Site | Cluj Napoca | |
Romania | Can-Fite Investigational Site | Iasi | |
Serbia | Can-Fite Investigational Site | Belgrade | |
Serbia | Can-Fite Investigational Site | Niska Banja | |
Serbia | Can-Fite Investigational Site | Zemun | |
Ukraine | Can-Fite Investigational Site | Kiev | |
Ukraine | Can-Fite Investigational Site | Kiev | |
Ukraine | Can-Fite Investigational Site | Kiev, | |
Ukraine | Can-Fite Investigational Site | Kiev, | |
United States | Can-Fite Investigational Site | Albany | New York |
United States | Can-Fite Invesitigational Site | Cleveland | Ohio |
United States | Can-Fite Investigational Site | Peoria | Arizona |
United States | Can-Fite Investigational Site | Perrysburg | Ohio |
United States | Can-Fite Investigational Site | Sugar Land | Texas |
Lead Sponsor | Collaborator |
---|---|
Can-Fite BioPharma |
United States, Bulgaria, Israel, Poland, Romania, Serbia, Ukraine,
Baharav E, Bar-Yehuda S, Madi L, Silberman D, Rath-Wolfson L, Halpren M, Ochaion A, Weinberger A, Fishman P. Antiinflammatory effect of A3 adenosine receptor agonists in murine autoimmune arthritis models. J Rheumatol. 2005 Mar;32(3):469-76. — View Citation
Szabo C, Scott GS, Virag L, Egnaczyk G, Salzman AL, Shanley TP, Hasko G. Suppression of macrophage inflammatory protein (MIP)-1alpha production and collagen-induced arthritis by adenosine receptor agonists. Br J Pharmacol. 1998 Sep;125(2):379-87. doi: 10.1038/sj.bjp.0702040. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR Efficacy Criteria | ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population | 12 weeks | |
Secondary | ACR Criteria Components | ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness. | 12 weeks | |
Secondary | Safety | Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs | 12 weeks |
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