NCT00556894

Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (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 addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

Detailed description

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 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) (with the exception of hydroxychloroquine), 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	orally q12h

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2007-11-12
• Last updated: 2018-03-29
• Results posted: 2015-03-09

Locations

26 sites across 6 countries: Bulgaria, Czechia, Israel, Poland, Serbia, Ukraine