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A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study 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

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Trial Profile

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study 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

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Masitinib (Primary) ; Methotrexate (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science

Most Recent Events

  • 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.
  • 25 Sep 2012 Planned end date changed from 1 Aug 2014 to 1 Dec 2015 as reported by ClinicalTrials.gov.

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