Rheumatoid Arthritis (RA) | Masitinib in Refractory Active Rheumatoid Arthritis
Rheumatoid Arthritis (RA) research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months 2. Patient with ACR functional class I-III 3. Patient who have active RA 4. 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 5. Patient with a disease onset at > 16 years of age Exclusion Criteria: 1. Patient for whom the use of methotrexate is contraindicated as per its SPC 2. Patient with documented fibromyalgia 3. Patient with lactose intolerance 4. Patient presenting with cardiac disorders
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Rheumatoid Arthritis (RA)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:masitinib 3 mg
Drug:masitinib 6.0 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
masitinib 3 mgmasitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 6.0 mgmasitinib 6.0 mg/kg/day, tablets, orally, twice a day
methotrexatemethotrexate at the dose of 15 or 20 mg per week
Start Date: July 2011
Completed Date: October 2015
Phase: Phase 2/Phase 3
Primary Outcome: ACR50
Secondary Outcome: ACR
Study sponsors, principal investigator, and references
Principal Investigator: Jacques Tebib, MD
Lead Sponsor: AB Science