Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed Rheumatoid arthritis patients with symptoms duration less than 24 months 2. Diagnosed as per ACR/EULAR classification criteria 3. DAS28 ESR more than 3.2
Exclusion criteria
Exclusion criteria: 1. Patients treated with DMARDs for more than 3 months prior to enrolment except HCQ 2. Patients treated with prednisolone in the past 1 month 3. Patients with evidence of hypothalamic pituitary adrenal axis suppression 4. Patients with absolute contraindication to corticosteroids as per treating physician 5. Presence of active infections 6. Patients who do not give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or intramuscular prednisone in addition to standard of care therapyTimepoint: Day 7 Day 30 Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in proportion of patients reporting EULAR good or moderate response at 2 months 2. Difference in trajectory of response in HAQ and RAPID 3 at day 7, 1month and 2 months 3. Difference in DAS 28 ESR improvement at 1 and 2 months 4. Difference in proportion of patients achieving delta HAQ more than 1.2 HAQ at days 7, day 30 and day 60 5. Differences in adverse effects Timepoint: Day 7 Day 30 Day 60 | — |
Countries
India
Contacts
St Johns Medical College and Hospital