| CTRI Number |
CTRI/2026/02/102919 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Intramuscular versus Oral Steroids in Rheumatoid arthritis: A comparative study |
|
Scientific Title of 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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sryla P B |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room 016407, Level 6, medicine office, Block-A (Academic block), All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9074485746 |
| Fax |
|
| Email |
drsrylapb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sryla P B |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room 016407, Level 6, medicine office, Block-A (Academic block), All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9074485746 |
| Fax |
|
| Email |
drsrylapb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sryla P B |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room 016407, Level 6, medicine office, Block-A (Academic block), All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9074485746 |
| Fax |
|
| Email |
drsrylapb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sryla P B |
| Address |
Room 016407, Level 6, medicine office, Block-A (Academic block), All India Institute of Medical Sciences, Rishikesh |
| 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 Sryla P B |
All India Institute of Medical Sciences, Rishikesh |
Room 016407, Level 6, medicine office, Block-A (Academic block), All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL |
9074485746
drsrylapb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intramuscular methylprednisone acetate |
Intramuscular MPS in low dose, 80mg 2 weekly, tapered according to disease activity, will be given for minimum 6 weeks in each arm. |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 < 100,000/µl (risk of intramuscular hematoma)
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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in validated disease activity measures (DAS-28 ESR, DAS-28 CRP, ACR20) |
24 weeks, 52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in validated disease activity measures (DAS-28 ESR, DAS-28 CRP, ACR20) |
24 weeks |
| Adverse events |
52 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 Yet Recruiting |
| 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 a double-blind, double dummy RCT to compare the efficacy of oral prednisone versus IM MPS in RA with moderate-high disease activity. The eligible patients will be recruited to either oral prednisone (with IM placebo) arm or IM MPS (with oral placebo) arm. The placebo being used is oral mutivitamin tablets for prednisone and normal saline in sealed sterile vials for IM MPS. The dose of treatment will be low-dose (7.5 mg of prednisone or 80mg of depomedrol) as per standard of care for RA. All patients will be given DMARDs as per institute policy, initiating from methotrexate, and adjusting dose as per treat-to-target policy. The disease activity and other measures will be followed up every 3 monthly or more frequently, as per disease activity of the patient. Any increase in disease activity requiring steroids during the trial duration will be treated with low-dose steroids as per arm of the patient, along with the placebo, to maintain blinding. All adverse effects will also be followed up. Primary outcome will be assessed at 1 year |