Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.

2. ACR functional class I-III

3. Have active RA

4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha

Exclusion Criteria:

1. Patient had a major surgery within 2 weeks prior to study entry.

2. Life expectancy < 6 months.