Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 70 years diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria. 2. Active disease defined by a Disease Activity Score-28 (DAS28) of >3.2. 3. Willingness to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those patients already in remission, as per ACR/EULAR provisional definition of remission. 2. Decompensated cardiac failure (New York Heart Association classification stage III or IV). 3. Platelet count 4. Active tuberculosis 5. Congenital or acquired immunodeficiency (including human immunodeficiency virus) 6. Chronic infection or infections requiring antimicrobial therapy within 1 month. 7. Concurrent presence of other autoimmune disorders 8. Current or past diagnosis of malignancy 9. Uncontrolled diabetes 10. Uncontrolled hypertension 11. Life expectancy of fewer than 2 years for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in validated disease activity measures (DAS-28 ESR, DAS-28 CRP, ACR20)Timepoint: 24 weeks, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in validated disease activity measures (DAS-28 ESR, DAS-28 CRP, ACR20)Timepoint: 24 weeks;Adverse eventsTimepoint: 52 weeks | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Rishikesh