Masitinib in Refractory Active Rheumatoid Arthritis

Sponsor
AB Science
Study ID
NCT01410695
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2011
Status verified
Dec 2018
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
324 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: masitinib 3 mg
    masitinib 3 mg/kg/day, tablets, orally, twice a day
  • Experimental: masitinib 6.0 mg
    masitinib 6.0 mg/kg/day, tablets, orally, twice a day
  • Active Comparator: methotrexate
    methotrexate at the dose of 15 or 20 mg per week

Primary Outcome Measure

ACR50 [ Time Frame: week 24 ]

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