NCT01034306

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Can-Fite BioPharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CF101	orally q12h
DRUG	Placebo control	orally q12 hours

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-12-17
• Last updated: 2022-05-24
• Results posted: 2015-03-09

Locations

5 sites across 2 countries: Bulgaria, Israel