Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
- Registration Number
- NCT00913432
- Lead Sponsor
- AB Science
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description masitinib 3 mg masitinib masitinib 3 mg/kg/day masitinib 6 mg masitinib masitinib 6 mg/kg/day
- Primary Outcome Measures
Name Time Method American College of Rheumatology Score 50 week 12
- Secondary Outcome Measures
Name Time Method DAS28 week 4, 8 and 12
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does masitinib target in rheumatoid arthritis treatment?
How does masitinib combination therapy compare to standard DMARDs in RA patients with inadequate response to methotrexate?
Which biomarkers are associated with response to masitinib in rheumatoid arthritis patients with anti-TNF failure?
What are the potential adverse events of masitinib at 3 and 6 mg/kg/day in combination with methotrexate for RA?
Are there alternative tyrosine kinase inhibitors being studied for rheumatoid arthritis in combination with methotrexate?