A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
This trial is active, not recruiting.
|Start date||March 2007|
|End date||March 2009|
|Trial size||20 participants|
|Trial identifier||NCT00913432, AB06010|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
masitinib 3 mg/kg/day
masitinib 6 mg/kg/day
American College of Rheumatology Score 50
time frame: week 12
time frame: week 4, 8 and 12
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA. 2. ACR functional class I-III 3. Have active RA 4. 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: 1. Patient had a major surgery within 2 weeks prior to study entry. 2. Life expectancy < 6 months.
|Official title||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|
|Principal investigator||Jacques Tebib, MD, PhD|
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