Efficacy of MabAsia (Adalimumab) in Rheumatoid Arthritis
Phase 3
- Conditions
- Rheumatoid Arthritis.Seropositive Rheumatoid Arthritis
- Registration Number
- IRCT2014090319025N1
- Lead Sponsor
- Vice Chancellor for research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
inclusion criteria:1-Age more 18 years old, 2- active Rheumatoid Arthritis, 3-not received Humira ® yet. exclusion criteria: 1-aminotransferase levels greater than twice the upper limit of normal and serum creatinine level more than 2mg/dL, a hemoglobin level of 8.5 mg/dL or less, platelet count less than 125000 cells/mm3, leukocyte count less than 3500 cells/mm3 3- Concomitant therapy with doses of oral corticosteroids greater than 10 mg of prednisone per day ,and NSAIDs with doses greater than the maximum dose recommended by the manufacturer
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to treatment for Rheumatoid Arthritis. Timepoint: Before beginning of treatment, after 3 months of treatment beginning, after 6 months of treatment beginning. Method of measurement: DAS 28 shows 20% improvement.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: Before intervention, After 3 months and after six months of therapy. Method of measurement: Clinically, by the rheumatologist, Cell Blood Count, Serum Biochemistry, Liver function test and Kidney function tests.