Does giving higher dose of folic acid improve intolerance associated with methotrexate in patients of Rheumatoid arthritis
Phase 4
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2023/04/051346
- Lead Sponsor
- PGIMER, Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age between 18 and 75 years
2. Diagnosis of RA made as per ACR EULAR 2010 criteria
3. Currently receiving methotrexate for more than 3 months
4. Methotrexate Intolerance Severity Assessment Score >4 qualifying as methotrexate intolerance
Exclusion Criteria
Unable to follow up at 16 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in primary intolerances at 16 weeks by MISA scoreTimepoint: Change in primary intolerances at 16 weeks by MISA score
- Secondary Outcome Measures
Name Time Method Change in DAS 28 3 variable score at 16 weeksTimepoint: 16 weeks;Change in RBC/Serum folate at the end of 16 weeksTimepoint: 16 weeks