Phase 2b/3 study in Rheumatoid Arthritis Masitinib vs Methotrexate V1
Research type
Research Study
Full title
A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, 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
IRAS ID
159448
Contact name
Alain Moussy
Contact email
Sponsor organisation
AB Science
Eudract number
2010-020992-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MUSC-3506, Study assigned to specialist Network
Duration of Study in the UK
2 years, 7 months, 28 days
Research summary
Inflammatory arthritic diseases, in particular rheumatoid arthritis (RA), are an important health problem. RA is an autoimmune disorder characterized by a chronic inflammation that can result in joint destruction, disability and premature death. Pre-clinical data has established that mast cells (MC; a type of cell found in blood) play vital role in the induction of RA and targeting these MC could prevent the development of joint inflammation. Thus, targeting mast cells could be an ideal remedy for this disease. Since the 90s, methotrexate is considered to be the reference treatment of RA. However, it has failed to achieve adequate disease control, indicating a need for improved therapy.
Masitinib (the drug under study) is already being developed as an anti-inflammatory agent and has been shown to inhibit (slow down) the function of mast cells and therefore may reduce the progression of RA.
This phase 2b/3 study is being carried out in 750 patients with RA, to compare the effectiveness and safety of masitinib (a tablet) to methotrexate (a capsule), in treatment of RA. Patients will be randomly chosen to go into 5 groups for different treatments:
group 1: 3 mg/kg/day masitinib + methotrexate placebo (150 patients),
group 2: 4.5 mg/kg/day masitinib+ methotrexate placebo (150 patients),
group 3: masitinib placebo + methotrexate (150 patients),
group 4: masitinib 3 mg/kg/day during 4 weeks then 4.5 mg/kg/day during 4 weeks then 6 mg/kg/day + methotrexate placebo (200 patients),
group 5: patients will receive masitinib placebo 3 mg/kg/day during 4 weeks then 4.5 mg/kg/day during 4 weeks then 6 mg/kg/day + methotrexate (100 patients).At week 12, in case of treatment failure/non response, patients will have the opportunity to withdraw from the main study and to enter an open-labeled escape arm with treatment of masitinib 4.5 mg/kg/day until week 24 and with possible extension.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0254
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion