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

Trial Profile

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

Discontinued
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
  • Most Recent Events

    • 07 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.
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