- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034306
Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
May 5, 2022 updated by: Can-Fite BioPharma
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sofia, Bulgaria, 1606
- Military Medical Academy
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Sofia, Bulgaria, 1359
- Multiprofile hospital for active treatment
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Sofia, Bulgaria, 1505
- Diagnostic Consultative Center Sofia
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Sofia, Bulgaria, 1612
- UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic
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Ashkelon, Israel
- Barzilai Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CF101 1 mg
piclidenoson (CF101) 1 mg tablet oral, Q12h for 12 weeks
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orally q12h
Other Names:
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Placebo Comparator: Placebo
placebo tablet to match the active, oral dosage, Q12h for 12 weeks
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orally q12 hours
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)
Time Frame: 12 weeks
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ACR20 Response is defined as a 20% improvement from baseline in disease:
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Achieving an ACR50 Response (50% Improvement)
Time Frame: 12 weeks
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ACR50 Response is defined as a 50% improvement from baseline in disease:
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12 weeks
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Number of Subjects Achieving an ACR70 Response (70% Improvement)
Time Frame: 12 weeks
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ACR70 Response is defined as a 70% improvement from baseline in disease:
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF101-204RA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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