NCT00913432

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

A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	masitinib	3 mg/kg/day oral route
DRUG	masitinib	masitinib 6 mg/kg/day oral route

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-06-01
• Completion: 2010-09-01
• First posted: 2009-06-04
• Last updated: 2018-12-13