| CTRI Number |
CTRI/2025/08/093740 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of low-dose short-term oral methylprednisolone compared to single intramuscular dose in bridge therapy for rheumatoid arthritis |
|
Scientific Title of Study
|
Evaluating the effectiveness of low-dose short-term oral methylprednisolone compared to single intramuscular dose in bridge therapy for rheumatoid arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnupriya Duddugunta |
| Designation |
DrNB Resident |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College and Hospital
Sarjapur Road
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
8328034060 |
| Fax |
|
| Email |
vishnupriyaa18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Shobha |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College and Hospital
Sarjapur Road
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9731947556 |
| Fax |
|
| Email |
vineeta0204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineeta Shobha |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College and Hospital
Sarjapur Road
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9731947556 |
| Fax |
|
| Email |
vineeta0204@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College and Hospital
Bengaluru-560034 |
|
|
Primary Sponsor
|
| Name |
Dr Vishnupriya Duddugunta |
| Address |
Department of clinical immunology and rheumatology
St Johns Medical college and hospital
Bengaluru |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnupriya Duddugunta |
St Johns Medical College |
Department of clinical immunology and rheumatology
St Johns Medical College and Hospital
Bengaluru
Bangalore
KARNATAKA |
8328034060
vishnupriyaa18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate |
All the patients will receive standard of care as per ACR/EULAR guidelines for rheumatoid arthritis and they will be on treatment with weekly methotrexate initiated at 15mg per week with folic acid supplementation and NSAIDs as required, with dose increments or addition of other DMARDs after 4 weeks if necessary. |
| Intervention |
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 a single dose of equivalent intramuscular depot methylprednisolone acetate.
Both arms will have equivalent dose of corticosteroids. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 therapy |
Day 7
Day 30
Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 7
Day 30
Day 60 |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open label randomised control trial from a single centre in India for evaluating the effectiveness of low dose short term oral methylprednisolone compared to a single intramuscular dose in bridge therapy for Rheumatoid arthritis. The primary outcome is to estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or intramuscular methylprednisolone in addition to standard of care therapy. Th secondary outcomes are to estimate difference in proportion of patients reporting EULAR good or moderate response at 2 months, difference in trajectory of response in HAQ and RAPID 3 at day 7, day 30 and day 60, difference in DAS 28 ESR improvement at day 30 and day 60, difference in proportion of patients achieving delta HAQ more than 1.2 at day 7, day 30 and day 60, differences in adverse effects. |