NCT00913432CompletedPhase 2
A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
AB Science0 sites20 target enrollmentStarted: March 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- American College of Rheumatology Score 50
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
- •ACR functional class I-III
- •Have active RA
- •Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha
Exclusion Criteria
- •Patient had a major surgery within 2 weeks prior to study entry.
- •Life expectancy < 6 months.
Arms & Interventions
masitinib 3 mg
Experimental
masitinib 3 mg/kg/day
Intervention: masitinib (Drug)
masitinib 6 mg
Experimental
masitinib 6 mg/kg/day
Intervention: masitinib (Drug)
Outcomes
Primary Outcomes
American College of Rheumatology Score 50
Time Frame: week 12
Secondary Outcomes
- DAS28(week 4, 8 and 12)
Investigators
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