To find out which is better mode of steroid therapy for early Rheumatoid arthritis.
Phase 2
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2023/11/059794
- Lead Sponsor
- Dr Vineeta Shobha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
RA patients (newly diagnosed)
DAS28 ESR greater 3.2
Exclusion Criteria
younger than 18 years
older than 75 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or parenteral (IM) prednisone in addition to SoC therapy. <br/ ><br>[EULAR Good response is defined as DAS28 =3.2 & a decline by 1.2. <br/ ><br>Moderate response is defined as a DAS28 =3.2 plus a decrease 0.6 and =1.2, OR a DAS28 =5.1 3.2 plus decline of 0.6, OR a DAS28 5.1 and a decrease 1.2] <br/ ><br>Timepoint: 30days
- Secondary Outcome Measures
Name Time Method Difference in proportion of patients reporting EULAR good or moderate response at 2 months <br/ ><br>Difference in trajectory of response in HAQ & RAPID 3 at day 7, 1month & 2 months <br/ ><br>Difference in DAS 28 ESR improvement at 1 & 2 months <br/ ><br>Difference in proportion of patients achieving delta HAQ 1.2 HAQ at baseline, 7 days (telephonic), 1 month & 2 months <br/ ><br>Cost effectiveness of the 2 arms of treatment <br/ ><br>Differences in adverse effects <br/ ><br>Timepoint: 8 months