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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- ACR50
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
- •Patient with ACR functional class I-III
- •Patient who have active RA
- •Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
- •Patient with a disease onset at > 16 years of age
Exclusion Criteria
- •Patient for whom the use of methotrexate is contraindicated as per its SPC
- •Patient with documented fibromyalgia
- •Patient with lactose intolerance
- •Patient presenting with cardiac disorders
Arms & Interventions
masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
Intervention: masitinib 3 mg (Drug)
masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
Intervention: Placebo (methotrexate) (Drug)
masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
Intervention: masitinib 6.0 mg (Drug)
masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
Intervention: Placebo (methotrexate) (Drug)
methotrexate
methotrexate at the dose of 15 or 20 mg per week
Intervention: methotrexate (Drug)
methotrexate
methotrexate at the dose of 15 or 20 mg per week
Intervention: Placebo (masitinib) (Drug)
Outcomes
Primary Outcomes
ACR50
Time Frame: week 24
Secondary Outcomes
- ACR(week 12)