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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: CF101 Drug: Placebo control | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034306
Bulgaria | |
Multiprofile Hospital for Active Treatment | |
Sofia, Bulgaria, 1359 | |
Diagnostic Consultative Center Sofia | |
Sofia, Bulgaria, 1505 | |
Military Medical Academy | |
Sofia, Bulgaria, 1606 | |
UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic | |
Sofia, Bulgaria, 1612 | |
Israel | |
Barzilai Medical Center | |
Ashkelon, Israel |
Study Director: | Michael H Silverman, MD | BioStrategics Consulting Ltd |
Responsible Party: | Can-Fite BioPharma |
ClinicalTrials.gov Identifier: | NCT01034306 |
Other Study ID Numbers: |
CF101-204RA |
First Posted: | December 17, 2009 Key Record Dates |
Results First Posted: | March 9, 2015 |
Last Update Posted: | March 9, 2015 |
Last Verified: | March 2014 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |