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Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by:
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00280917
First received: January 23, 2006
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Can-Fite BioPharma:

Primary Outcome Measures:
  • ACR efficacy criteria

Secondary Outcome Measures:
  • ACR criteria components
  • Safety

Estimated Enrollment: 252
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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 unchanged doses for >=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, CF101 4 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, duration of morning stiffness, 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, 12, and 14.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280917

  Hide Study Locations
Locations
United States, Arizona
Can-Fite Investigational Site
Peoria, Arizona, United States, 85381
United States, New York
Can-Fite Investigational Site
Albany, New York, United States, 12206
United States, Ohio
Can-Fite Invesitigational Site
Cleveland, Ohio, United States, 44195
Can-Fite Investigational Site
Perrysburg, Ohio, United States, 43551
United States, Texas
Can-Fite Investigational Site
Sugarland, Texas, United States, 77479
Bulgaria
Can-Fite Investigational Site
Plovdiv, Bulgaria, 4002
Can-Fite Investigational Site
Sofia, Bulgaria, 1612
Can-Fite Investigational Site
Sofia, Bulgaria, 1233
Can-Fite Investigational Site
Stara Zagora, Bulgaria, 6000
Israel
Can-Fite Investigational Sites
Afula, Israel
Can-Fite Investigational Site
Ashkelon, Israel, 78278
Can-Fite Investigational Site
Beer Yaakov, Israel, 70300
Can-Fite Investigational Site
Haifa, Israel, 31096
Can-Fite Investigational Site
Haifa, Israel, 77479
Can-Fite Investigational Site
Jerusalem, Israel, 91120
Can-Fite Investigational Site
Jerusalem, Israel, 91031
Can-Fite Investigational Site
Jerusalem, Israel
Can-Fite Investigational Site
Kfar-Saba, Israel, 44281
Can-Fite Investigational Site
Tel Hashomer, Israel, 52621
Poland
Can-Fite Investigational Site
Białystok, Poland, 15-297
Can-Fite Investigational Site
Lublin, Poland, 20-022
Can-Fite Investigational Site
Sopot, Poland, 81-759
Can-Fite Investigational Site
Szczecin, Poland, 71-252
Romania
Can-Fite Investigational Site
Brasov, Romania, 500356
Can-Fite Investigational Site
Bucharest, Romania, 020983
Can-Fite Investigational Site
Bucharest, Romania, 020125
Can-Fite Investigational Site
Cluj Napoca, Romania, 400006
Can-Fite Investigational Site
Iasi, Romania, 700661
Serbia
Can-Fite Investigational Site
Belgrade, Serbia, 11000
Can-Fite Investigational Site
Niska Banja, Serbia, 18205
Can-Fite Investigational Site
Zemun, Serbia, 11080
Ukraine
Can-Fite Investigational Site
Kiev, Ukraine, 04053
Can-Fite Investigational Site
Kiev, Ukraine, 03680
Can-Fite Investigational Site
Kiev,, Ukraine, 01103
Can-Fite Investigational Site
Kiev,, Ukraine, 01023
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
Study Director: Michael H Silverman, MD BioStrategics Consulting Ltd
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00280917     History of Changes
Other Study ID Numbers: CF101-202RA
Study First Received: January 23, 2006
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Can-Fite BioPharma:
Rheumatoid Arthritis
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014