Rheumatoid Arthritis Clinical Trial
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
Verified date | February 2022 |
Source | Can-Fite BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Diagnostic Consultative Center Sofia | Sofia | |
Bulgaria | Military Medical Academy | Sofia | |
Bulgaria | Multiprofile Hospital for Active Treatment | Sofia | |
Bulgaria | UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic | Sofia | |
Israel | Barzilai Medical Center | Ashkelon |
Lead Sponsor | Collaborator |
---|---|
Can-Fite BioPharma |
Bulgaria, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement) | ACR20 Response is defined as a 20% improvement from baseline in disease: >20% improvement in tender joint count (TJC), and >20% improvement in swollen joint count (SJC), and >20% improvement in at least 3 of following 5: Physician global assessment (PGA), Patient global assessment (PAGA), Patient pain assessment (PPA), Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and Most improved response of ESR and CRP |
12 weeks | |
Secondary | Number of Subjects Achieving an ACR50 Response (50% Improvement) | ACR50 Response is defined as a 50% improvement from baseline in disease: >50% improvement in TJC, and >50% improvement in SJC, and >50% improvement in at least 3 of following 5: Physician global assessment (PGA), Patient global assessment (PAGA), Patient pain assessment (PPA), Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and Most improved response of ESR and CRP |
12 weeks | |
Secondary | Number of Subjects Achieving an ACR70 Response (70% Improvement) | ACR70 Response is defined as a 70% improvement from baseline in disease: >70% improvement in TJC, and >70% improvement in SJC, and >70% improvement in at least 3 of following 5: Physician global assessment (PGA), Patient global assessment (PAGA), Patient pain assessment (PPA), Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and Most improved response of ESR and CRP |
12 weeks |
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