Status:
COMPLETED
Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
Lead Sponsor:
AB Science
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 art...
Eligibility Criteria
Inclusion
- 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
- Patient had a major surgery within 2 weeks prior to study entry.
- Life expectancy \< 6 months.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00913432
Start Date
March 1 2007
End Date
September 1 2010
Last Update
December 13 2018
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