Sponsor decision based on portfolio prioritization

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.

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