| CTRI Number |
CTRI/2025/04/085746 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
“A Study on a Rare Lupus Complication: Symptoms, Diagnosis, and Treatment Outcomes” |
|
Scientific Title of Study
|
A retrospective cohort study on macrophage activation syndrome in Indian Patients with systemic lupus erythematosus: clinical features, laboratory abnormalities and treatment outcomes |
| 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 Nilesh Nolkha |
| Designation |
Senior Consultant |
| Affiliation |
Topiwala National Medical College |
| Address |
Dpt of Rheumatology
Topiwala National Medical College
Mumbai-400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9920355665 |
| Fax |
|
| Email |
Drnileshnolkha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavyasree |
| Designation |
Senior Resident |
| Affiliation |
Topiwala National Medical College |
| Address |
Dpt of rheumatology
Topiwala National Medical college
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9496660940 |
| Fax |
|
| Email |
Kavuttysunil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavyasree |
| Designation |
Senior Resident |
| Affiliation |
Topiwala National Medical College |
| Address |
Dpt of rheumatology
Topiwala National Medical college
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9496660940 |
| Fax |
|
| Email |
Kavuttysunil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College
Dr AL Nair Road
Mumbai Central
Mumbai-400008 |
|
|
Primary Sponsor
|
| Name |
Topiwala national medical college |
| Address |
Topiwala National Medical College
Dr AL Nair Road
Mumbai Central
Mumbai-400008 |
| Type of Sponsor |
Other [Not sponsored ] |
|
|
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 Kavyasree |
Topiwala National Medical College |
OPD 40
OPD Building 1st floor
Topiwala National Medical College
Dr AL Nair Road
Mumbai Central
Mumbai-400008
Mumbai
MAHARASHTRA |
9496660940
Kavuttysunil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECARP |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of SLE as per ACR/EULAR 2019 classification criteria10
Diagnosed as a case of MAS as per one of the three above-mentioned criteria
Diagnosed to have MAS between 2004 to 2024 |
|
| ExclusionCriteria |
| Details |
Unclear diagnosis of MAS (i.e. not satisfying either of the three mentioned criteria)
MAS because of causes other than SLE disease activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Resolution of MAS: Defined by clinical improvement and normalization of laboratory markers (ferritin, liver enzymes, blood counts) after treatment.
Time to Resolution: Duration from diagnosis of MAS to clinical and laboratory resolution. |
Since it’s retrospective, time points can be based on clinical records:
1. Baseline: At MAS diagnosis (clinical presentation and lab abnormalities).
2. Early Response: Within 7 days of initiating treatment.
3. Intermediate Response: 2–4 weeks after treatment initiation.
4. Final Outcome: At 3 months post-diagnosis or last follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes for MAS in SLE Study
1. Clinical Outcomes
2. Laboratory Outcomes
3. Treatment Outcomes
4. Long-Term Outcomes |
Baseline- at diagnosis
Early response -7-14 days
Intermediate- at 4 weeks
Final outcome-4months
Extended followup-6-12months |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
15/05/2025 |
| 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="0"
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 retrospective cohort study where patients of SLE (Satisfying ACR/EULAR 2019 classification criteria) would be enrolled if they satisfy at least one of the three prevalent criteria for diagnosing primary or secondary Hemophagocytic Lymphohistiocytosis (HLH)7,8,9. History, clinical examination findings and investigations done at the time of diagnosis of macrophage activation are enrolled in the case record form. No additional investigations are being done as a part of this study. |