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Trial record 4 of 4 for:    cf101 rheumatoid arthritis

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01034306
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Tracking Information
First Submitted Date  ICMJE December 16, 2009
First Posted Date  ICMJE December 17, 2009
Results First Submitted Date  ICMJE February 24, 2015
Results First Posted Date  ICMJE March 9, 2015
Last Update Posted Date March 9, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
American College of Rheumatology (ACR20) [ Time Frame: 12 weeks ]
Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
American College of Rheumatology (ACR20) [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
  • Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing [ Time Frame: 12 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
Official Title  ICMJE A Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors
Brief Summary This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at baseline will relieve signs and symptoms of the disease.
Detailed Description This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, study in which patients with active RA and high A3AR expression at baseline will be randomized to the addition of either CF101 1.0 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), 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: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CF101
    orally q12h
    Other Name: IB-MECA
  • Drug: Placebo control
    orally q12 hours
    Other Name: Inactive pill
Study Arms  ICMJE
  • Experimental: CF101 1 mg
    Intervention: Drug: CF101
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo control
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: March 26, 2014)
79
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2009)
80
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (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, 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 either: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
  • Elevated PBMC A3AR expression level, defined as >= 1.5-fold over a predetermined normal population standard, following the appropriate DMARD/biologic washout period (see Exclusion Criteria) but within 2 weeks of beginning dosing
  • If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification Visit, 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 A3AR Qualification Visit, and will remain unchanged during protocol participation
  • In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
  • 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)
  • All aspects of the protocol explained and written informed consent obtained

Exclusion Criteria:

  • Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
  • Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
  • Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
  • Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
  • Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
  • Receipt of rituximab at any previous time
  • Previous failure to respond to methotrexate or any anti-rheumatic biological agent
  • 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 the A3AR Qualification Visit
  • Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit
  • Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit
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,   Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01034306
Other Study ID Numbers  ICMJE CF101-204RA
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 March 2014

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