drugset / Trial / NCT01410695
Masitinib in Refractory Active Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Masitinib | Small molecule | 3 mg/kg | Oral |
| Subject | Masitinib | Small molecule | 6 mg/kg | Oral |
| Comparator | Methotrexate | Small molecule | 15 mg | — |
| Comparator | Methotrexate | Small molecule | 20 mg | — |