| CTRI Number |
CTRI/2025/04/086074 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of role of oral steroid sparing agent in prevention of relapse |
|
Scientific Title of Study
|
Assessment of the utility of addition of oral immunosuppressant in pemphigus vulgaris PV patients receiving rituximab infusion RA protocol and oral prednisolone a pilot, randomized open-label 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 |
Dr Shreya K |
| Designation |
Senior Resident AIIMS New Delhi |
| Affiliation |
MD DNB Department of dermatology, All India Institute of medical sciences, New Delhi |
| Address |
Room 308, New RAK OPD, Department of dermatology, venereology, AIIMS Delhi, ansari nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8296529521 |
| Fax |
|
| Email |
shreyakgowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujay Khandpur |
| Designation |
Professor |
| Affiliation |
MD FAMS |
| Address |
Room 4070, New RAK OPD, Department of dermatology, venereology, AIIMS Delhi, ansari nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8296529521 |
| Fax |
|
| Email |
sujay_khandpur@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya K |
| Designation |
Senior Resident Department of Dermatology and Venereology |
| Affiliation |
MD DNB Department of dermatology, venereology, All India Institute of Medical sciences, Delhi, ansari nagar, New Delhi |
| Address |
Room 308, New RAK OPD, Department of dermatology, venereology, AIIMS Delhi, ansari nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8296529521 |
| Fax |
|
| Email |
shreyakgowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi MD/MCH/DM grant, ansari nagar, New Delhi 110029
|
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
Ansari nagar AIIMS delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 shreya k |
All India Institute of Medical Sciences New Delhi |
Room 4070, All India Institute of Medical Sciences New Delhi, ansari nagar, New Delhi 110029
New Delhi
DELHI |
8296529521
shreyakgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Delhi |
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 |
rituximab |
Intravaenous rituximab(rheumatoid arthritis protocol, both groups)
Patients will receive 2 doses of 1g RTX infusion, two weeks apart. |
| Comparator Agent |
rituximab with oral immunosupressant |
Additional oral immunosuppressant (group B)
In group B, along with rituximab (rheumatoid arthritis protocol) and daily oral prednisolone in tapering schedule (as per PDAI), tablet azathioprine, 50mg twice daily, will be administered. Daily oral azathioprine will be continued for one year after achieving remission off oral prednisolone. In patients who are contraindicated or intolerant to azathioprine, it will be substituted with oral MMF, 1g twice daily or mycophenolate sodium 720mg twice daily (if GI intolerance to MMF).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Consenting confirmed patients of active mucocutaneous PV of any severity, aged 18-70 years, of any gender, which are planned for rituximab therapy and admitted to the dermatology ward and daycare center, will be recruited. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of relapsing patients in rituximab infusion (RA protocol) with oral prednisolone group versus rituximab, oral prednisolone, and oral immunosuppressant group during 2 years study period |
baseline, 3months, remission, relapse |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to disease relapse between the two groups |
2 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/05/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreyakgowda@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 16-11-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
As per literature search, there is no prospective head-to-head randomized study to assess the utility of additional oral immunosuppressant in patients of pemphigus vulgaris receiving the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule Research question: Does the addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule, offer additional benefit in terms of clinical and immunological efficacy in PV Research hypothesis: The addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule, offers additional benefit in terms of clinical and immunological efficacy Null hypothesis: The addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule does not offer additional benefit in terms of clinical and immunological efficacy in PV |