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Sponsored by: |
Can-Fite BioPharma |
---|---|
Information provided by: | Can-Fite BioPharma |
ClinicalTrials.gov Identifier: | NCT00556894 |
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.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: CF101 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis |
Estimated Enrollment: | 230 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CF101 0.1 mg
|
Drug: CF101
orally q12h
|
2: Experimental
CF101 1 mg
|
Drug: CF101
orally q12h
|
3: Placebo Comparator
Placebo
|
Drug: CF101
orally q12h
|
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 unchanged doses for >=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for >=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Clinic of Rheumatology at MHAT 'Sveti Ivan Rilski' | |
Sofia, Bulgaria, 1612 | |
Clinic of internal diseases at NMTH 'Tzar Boris Treti' | |
Sofia, Bulgaria | |
Clinic of Rheumatology at MHAT 'Sveti Georgi' | |
Plovdiv, Bulgaria, 4002 | |
Second Clinic of Internal Diseases at MHAT 'Stara Zagora' | |
Stara Zagora, Bulgaria, 6000 | |
Clinic of Rheumatology at MHAT 'Sveta Marina' - Varna | |
Varna, Bulgaria, 9010 | |
Israel | |
Rambam Medical Center | |
Haifa, Israel, 31096 | |
Meir Medical Center | |
Kfar-Saba, Israel, 44281 | |
Barzilai Medical Center | |
Ashkelon, Israel, 78278 | |
Hadassah Har-Hazofim Medical Center | |
Jerusalem, Israel | |
Poland | |
Samodzielny Publiczny Szpital Kliniczny Nr 1 P.A.M. w Szczecinie | |
Szczecin, Poland, 71252 | |
Wojewodzki Zespol Reumatologiczny w Sopocie | |
Sopot, Poland, 81967 | |
Niepubliczny Zaklad Opieki Zdrowotnej | |
Lublin, Poland, 20607 | |
Wojewodzki Szpital Zespolony w Elblagu | |
Elblag, Poland, 82300 | |
Niepubliczny Zaklad Opieki Zdrowotnej "NASZ LEKARZ" | |
Torun, Poland, 87100 | |
Serbia | |
Institute of Rheumatology - Belgrade | |
Belgrade, Serbia, 11000 | |
Institute of Rheumatology - Belgrade | |
Belgrade, Serbia, 11000 | |
Institute of Rheumatology - Belgrade | |
Belgrade, Serbia, 11000 | |
Institute for Prevention, Treatment, and Rehabilitation of Rheumatoid and Cardiovascular Diseases Niska Banja | |
Niska Banja, Serbia, 18205 | |
Ukraine | |
O.O. Bogomolets National Medical University | |
Kiev, Ukraine, 04053 | |
National Scientific Centre of AMS of Ukraine | |
Kiev, Ukraine, 03680 | |
City Clinical Hospital N12 | |
Kiev, Ukraine, 01103 | |
Vinnitsya Regional Clinical Hospital | |
Vinnycia, Ukraine, 21018 | |
Central Municipal Clinical Hospital nº1 | |
Donetsk, Ukraine, 83114 | |
Kyiv Central Municipal Hospital | |
Kiev, Ukraine, 01023 |
Study Director: | Michael H Silverman, MD | BioStrategics Consulting Ltd |
Responsible Party: | Can-Fite BioPharma Ltd ( Michael H Silverman, MD ) |
Study ID Numbers: | CF101-203RA |
Study First Received: | November 8, 2007 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00556894 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Signs and Symptoms Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |