Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis
Verified date | August 2011 |
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 | 253 |
Est. completion date | April 2009 |
Est. primary completion date | March 2009 |
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 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Clinic of Rheumatology at MHAT 'Sveti Georgi' | Plovdiv | |
Bulgaria | Clinic of internal diseases at NMTH 'Tzar Boris Treti' | Sofia | |
Bulgaria | Clinic of Rheumatology at MHAT 'Sveti Ivan Rilski' | Sofia | |
Bulgaria | Second Clinic of Internal Diseases at MHAT 'Stara Zagora' | Stara Zagora | |
Bulgaria | Clinic of Rheumatology at MHAT 'Sveta Marina' - Varna | Varna | |
Czechia | University Hospital Hradec Kralove | Hradec Kralove | |
Czechia | Institute of Rheumatology | Prague | |
Czechia | Rheumotology Out-patient Clinic | Zlin | |
Israel | Haemek Medical Center | Afula | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Rambam Medical Center | Haifa | |
Israel | Hadassah Har-Hazofim Medical Center | Jerusalem | |
Israel | Meir Medical Center | Kfar-Saba | |
Poland | Wojewodzki Szpital Zespolony w Elblagu | Elblag | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej | Lublin | |
Poland | Wojewodzki Zespol Reumatologiczny w Sopocie | Sopot | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 P.A.M. w Szczecinie | Szczecin | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej "NASZ LEKARZ" | Torun | |
Serbia | Institute of Rheumatology - Belgrade | Belgrade | |
Serbia | Institute for Prevention, Treatment, and Rehabilitation of Rheumatoid and Cardiovascular Diseases Niska Banja | Niska Banja | |
Ukraine | Central Municipal Clinical Hospital nº1 | Donetsk | |
Ukraine | City Clinical Hospital N12 | Kiev | |
Ukraine | Kyiv Central Municipal Hospital | Kiev | |
Ukraine | National Scientific Centre of AMS of Ukraine | Kiev | |
Ukraine | O.O. Bogomolets National Medical University | Kiev | |
Ukraine | Vinnitsya Regional Clinical Hospital | Vinnycia |
Lead Sponsor | Collaborator |
---|---|
Can-Fite BioPharma |
Bulgaria, Czechia, Israel, Poland, Serbia, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR20 at Week 12 | Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria | 12 weeks | |
Secondary | ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters | ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses | 12 weeks |
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