Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligible participants will be RA patients aged equal to or greater than 19 years, diagnosed by a consultant rheumatologist and satisfying 2010 American College of Rheumatology and EULAR classification criteria for rheumatoid arthritis. Only patients with stable disease receiving same MTX dose during preceding 6 weeks will be included. Patients on hydroxychloroquine or low-dose steroids, that is less than 5 mg prednisolone or equivalent are allowed.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria are patients taking combination DMARDs therapy, MTX with biological DMARDs, or MTX with targeted synthetic DMARDs use. 2.Patients with a history of anaphylaxis to any vaccine, those with fever at vaccination time, past history of demyelinating syndromes, pregnant or lactating women. 3.RA patients with overlap with other rheumatic diseases except secondary Sj gren s syndrome will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients with a satisfactory vaccine response in both groupsTimepoint: 4 weeks 3 months 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include analysis of factors affecting seroconversion status, recording adverse reactions and monitoring incidences of pneumonia or suspected invasive pneumococcal infections during the study period.Timepoint: 4 weeks 3 months 6 months | — |
Countries
India
Contacts
Institute OF Rheumatology, RGGGH & Madras Medical College