A multicentre, randomised, double-blind, placecbo-controlled, 3-parallel groups, phase IIb/III study to compare the efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate in the treatment of patients with active rheumatoid arthritis with inadequate response to 1. Methotrexate or to 2. Any Disease-modifying anti-rheumatic drug (DMARD) including at least one biologic drug if patients previously failed methotrexate or to 3. Methotrexate in combination with any DMARD including biologic drugs
Phase of Trial: Phase II/III
Latest Information Update: 15 May 2017
At a glance
- Drugs Masitinib (Primary) ; Methotrexate (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors AB Science
- 10 Jun 2017 Biomarkers information updated
- 21 Sep 2015 Status changed from recruiting to discontinued, according to an AB Science media release.
- 21 Sep 2015 According to an AB Science media release, the company has decided to stop this study. This decision was made based on a futility test, conducted by the external Data and Safety Monitoring Board (DSMB), showing that the probability of success on the primary endpoint was below 50% for this study, including the resampling option. The company policy is to focus on indications with a predictive probability of success greater than 50% and a high medical need.