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Efficacy of Intramuscular versus Oral Steroids in Rheumatoid arthritis: A comparative study

EFFICACY OF ORAL PREDNISONE VERSUS INTRAMUSCULAR DEPOT METHYLPREDNISOLONE ACETATE FOR REDUCTION OF DISEASE ACTIVITY IN EARLY RHEUMATOID ARTHRITIS WITH MODERATE TO SEVERE DISEASE ACTIVITY: A DOUBLE-BLIND EXPLORATORY RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102919
Enrollment
40
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Oral Prednisone: Oral Prednisone in low dose, starting at 7.5mg, and tapered according to disease activity, will be given for minimum 6 weeks in each arm. Control Intervention1: Intramu

Sponsors

Sryla P B
Lead Sponsor

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

MeasureTime frame
Mean change in validated disease activity measures (DAS-28 ESR, DAS-28 CRP, ACR20)Timepoint: 24 weeks, 52 weeks

Secondary

MeasureTime 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

Public ContactSryla P B

All India Institute of Medical Sciences, Rishikesh

drsrylapb@gmail.com9074485746

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026