Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT01034306
First received: December 16, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CF101
Drug: Placebo control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Can-Fite BioPharma:

Primary Outcome Measures:
  • American College of Rheumatology (ACR20) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse event reporting, physical examination, vital signs, clinical laboratory testing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CF101 1 mg Drug: CF101
orally q12h
Other Name: IB-MECA
Placebo Comparator: Placebo Drug: Placebo control
orally q12 hours
Other Name: Inactive pill

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.

  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 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
  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: NCT01034306

Locations
Bulgaria
Diagnostic Consultative Center Sofia
Sofia, Bulgaria, 1505
Military Medical Academy
Sofia, Bulgaria, 1606
UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic
Sofia, Bulgaria, 1612
Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1359
Israel
Barzilai Medical Center
Ashkelon, Israel
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
Study Director: Michael H Silverman, MD BioStrategics Consulting Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT01034306     History of Changes
Other Study ID Numbers: CF101-204RA
Study First Received: December 16, 2009
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014