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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
orally q12h
orally q12 hours
Multiprofile Hospital for Active Treatment
Sofia, Bulgaria
Diagnostic Consultative Center Sofia
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic
Sofia, Bulgaria
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: 1. \>20% improvement in tender joint count (TJC), and 2. \>20% improvement in swollen joint count (SJC), and 3. \>20% improvement in at least 3 of following 5: 1. Physician global assessment (PGA), 2. Patient global assessment (PAGA), 3. Patient pain assessment (PPA), 4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and 5. Most improved response of ESR and CRP
Time frame: 12 weeks
Number of Subjects Achieving an ACR50 Response (50% Improvement)
ACR50 Response is defined as a 50% improvement from baseline in disease: 1. \>50% improvement in TJC, and 2. \>50% improvement in SJC, and 3. \>50% improvement in at least 3 of following 5: 1. Physician global assessment (PGA), 2. Patient global assessment (PAGA), 3. Patient pain assessment (PPA), 4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and 5. Most improved response of ESR and CRP
Time frame: 12 weeks
Number of Subjects Achieving an ACR70 Response (70% Improvement)
ACR70 Response is defined as a 70% improvement from baseline in disease: 1. \>70% improvement in TJC, and 2. \>70% improvement in SJC, and 3. \>70% improvement in at least 3 of following 5: 1. Physician global assessment (PGA), 2. Patient global assessment (PAGA), 3. Patient pain assessment (PPA), 4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and 5. Most improved response of ESR and CRP
Time frame: 12 weeks
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Barzilai Medical Center
Ashkelon, Israel