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Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00556894
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : March 9, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Tracking Information
First Submitted Date  ICMJE November 8, 2007
First Posted Date  ICMJE November 12, 2007
Results First Submitted Date  ICMJE February 24, 2015
Results First Posted Date  ICMJE March 9, 2015
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
ACR20 at Week 12 [ Time Frame: 12 weeks ]
Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
ACR20 [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
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 [ Time Frame: 12 weeks ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
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 [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients
Official Title  ICMJE 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
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 inflammation despite taking methotrexate for at least 6 months.
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, 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CF101
    orally q12h
    Other Name: IB-MECA
  • Drug: Placebo
    orally q12h
Study Arms  ICMJE
  • Experimental: CF101 0.1 mg
    CF101 0.1 mg was given orally q12h
    Intervention: Drug: CF101
  • Experimental: CF101 1 mg
    CF101 1 mg was given orally q12h
    Intervention: Drug: CF101
  • Placebo Comparator: Placebo
    Matched placebo was given orally q12h
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
253
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2007)
230
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Israel,   Poland,   Serbia,   Ukraine
Removed Location Countries Czech Republic,   Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00556894
Other Study ID Numbers  ICMJE CF101-203RA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Can-Fite BioPharma
Study Sponsor  ICMJE Can-Fite BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael H Silverman, MD BioStrategics Consulting Ltd
PRS Account Can-Fite BioPharma
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP