Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

Sponsor
AB Science
Study ID
NCT00913432
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • masitinib — DRUG
    3 mg/kg/day oral route
  • masitinib — DRUG
    masitinib 6 mg/kg/day oral route

Study Details

A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.

Key Dates

Start date
Mar 31, 2007
Status verified
Dec 2018
Primary completion
Jun 30, 2009
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: masitinib 3 mg
    masitinib 3 mg/kg/day
  • Experimental: masitinib 6 mg
    masitinib 6 mg/kg/day

Primary Outcome Measure

American College of Rheumatology Score 50 [ Time Frame: week 12 ]

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