NCT01410695

Masitinib in Refractory Active Rheumatoid Arthritis

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	masitinib 3 mg
DRUG	masitinib 6.0 mg
DRUG	methotrexate
DRUG	Placebo (methotrexate)
DRUG	Placebo (masitinib)

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-08-05
• Last updated: 2018-12-17

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated drug study