| CTRI Number |
CTRI/2025/06/089549 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Rituximab and its risk and benefits in treating patients with pemphigus. |
|
Scientific Title of Study
|
Efficacy and safety of Rituximab infusion in pemphigus patients: A retrospective 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 |
Dr Harshini S |
| Designation |
Post Graduate |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Room no 14, 1st floor, Department of Dermatology Venereology and Leprosy, HIMS, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09597494975 |
| Fax |
|
| Email |
harshummc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh MR |
| Designation |
Associate Professor |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Room no 14, 1st floor, Department of Dermatology Venereology and Leprosy, HIMS, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9480303929 |
| Fax |
|
| Email |
drsureshhsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshini S |
| Designation |
Post Graduate |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Room no 14, 1st floor, Department of Dermatology Venereology and Leprosy, HIMS, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09597494975 |
| Fax |
|
| Email |
harshummc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Harshini S |
| Address |
Room no 14, 1 st floor, Department of Dermatology Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan, Karnataka -573201 |
| 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 Harshini S |
Hassan Institute of Medical Sciences |
Room no 14, 1st floor, Department of Dermatology Venereology and Leprosy,Hassan Institute of Medical Sciences, Hassan
Hassan
KARNATAKA |
9597494975
harshummc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - HIMS, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L100||Pemphigus vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All pemphigus patients (fresh, relapse, and recalcitrant cases) with diagnosis confirmed by typical clinical presentation, direct immunofluorescence and biopsy who had received rituximab infusion
2. Patients with proper clinical records available.
3. Uninterrupted clinical follow-up of at least 12 months since the first rituximab treatment
|
|
| ExclusionCriteria |
| Details |
Patients with missed data and lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pemphigus Area and Activity Score (PAAS) |
Baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
07/07/2025 |
| 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="2"
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 retrospective study to assess the efficacy and safety of Rituximab infusion in pemphigus patients in our institute based on the records available in the department register. Rituximab was FDA approved in 2018 for the treatment of moderate to severe pemphigus vulgaris and it has been increasingly used and has revolutionized the treatment of immunobullous diseases resulting in the major shift of focus from more global immunosuppression to targeted immunotherapy. This study purpose is to provide critical analysis of use of rituximab in the treatment of pemphigus patients. |