| CTRI Number |
CTRI/2023/11/059463 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs,
Methylprednisolone and Dexamethasone in patients with Systemic Lupus Erythematosus |
|
Scientific Title of Study
|
Methylprednisolone versus Dexamethasone in the treatment of Systemic Lupus Erythematosus with moderate or severe disease activity:A Randomised, Open Label Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh Maslekar |
| Designation |
Senior Resident |
| Affiliation |
St Johns Medical College |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9880670806 |
| Fax |
|
| Email |
anirudh.maslekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Shobha |
| Designation |
Professor and HOD |
| Affiliation |
St Johns Medical College |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9845021146 |
| Fax |
|
| Email |
vineeta0204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirudh Maslekar |
| Designation |
Senior Resident |
| Affiliation |
St Johns Medical College |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9880670806 |
| Fax |
|
| Email |
anirudh.maslekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College
Sarjapur Road
Bangalore 560034 |
|
|
Primary Sponsor
|
| Name |
Dr Anirudh Maslekar |
| Address |
Department of Clinical Immunology and Rheumatology
St Johns Medical College
Sarjapur Road
Bangalore 560078 |
| 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 Anirudh Maslekar |
St Johns Medical College Hospital |
Dept of Clinical Immunology and Rheumatology
St Johns Medical College
Sarjapur Road
Bangalore 560034
Bangalore
KARNATAKA |
9880670806
anirudh.maslekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INJ DEXAMETHASONE |
8mg IV BD administered for 3 days |
| Intervention |
INJ METHYLPREDNISOLONE |
250mg IV OD administered for 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All hospitalised patients of Systemic Lupus Erythematosus (SLE) who have previously met or currently meet the 2012 SLICC and/or 2019 ACR criteria for SLE.
2.Moderate or severe disease activity as defined in The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults (2018) as :
a. Moderate disease activity-SLEDAI-2K score in the range of 6-12.
b. Severe disease activity-SLEDAI- 2K score of >12
|
|
| ExclusionCriteria |
| Details |
1.Age <18 years
2.Pregnancy
3.Hemodynamic instability and/or current ICU admission.
4.Diffuse alveolar haemorrhage.
5.Advanced renal disease –defined as eGFR <15ml/min and/or RPRF
6.Incomplete treatment records.
7.Concurrent microbiologically documented infection.
8.Any patient deemed to have a immediate increased risk of mortality as decided by the treating physician |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Achievement of SLEDAI-2K Responder Index-50 (SRI-50) improvement definition in the relevant parameters of SLEDAI-2K score between the two groups .
|
day 15 30 & 60 post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SLEDAI-2KG Score |
day 15 30 & 60 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2023 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This study is a randomized, open label, parallel group, single centre trial comparing the efficacy of Inj Methylprednisolone 125mg OD and Inj Dexamethasone 8mg BD daily for 3 days in 100 patients(50 in each group) with SLE having moderate or severe disease activity. SLEDAI-2K and SLEDAI-2KG score will be calculated at baseline. Following the intervention, all the patients will receive standard of care as per the British Society of Rheumatology(BSR) Guidelines(2018).The primary outcome measure will be achievement of SRI-50 improvement definitons in the relevant parameters of SLEDAI 2k score at baseline and day 60 in the two groups. The secondary outcomes will be SLEDAI 2KG score at day 60. |