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Effectiveness of low-dose short-term oral methylprednisolone compared to single intramuscular dose in bridge therapy for rheumatoid arthritis

Evaluating the effectiveness of low-dose short-term oral methylprednisolone compared to single intramuscular dose in bridge therapy for rheumatoid arthritis - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093740
Enrollment
114
Registered
2025-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

Interventions

Intervention1: Methylprednisolone: Based on patients preference they will be administered oral methylprednisolone 8mg daily for 5 days followed by 4mg daily for 5 days and 2mg daily for 10 days versus

Sponsors

Dr Vishnupriya Duddugunta
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Vineeta Shobha

St Johns Medical College and Hospital

vineeta0204@gmail.com9731947556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026