| CTRI Number |
CTRI/2024/07/070465 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Therapeutic efficacy of ultra-low dose rituximab in pemphigus vulgaris |
|
Scientific Title of Study
|
Therapeutic efficacy of ultra-low dose rituximab in pemphigus vulgaris: a pilot 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 |
Sandip Gupta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8423975276 |
| Fax |
|
| Email |
sandeepgup640@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871213543 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871213543 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Ansari Nagar, New 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 Sandip Gupta |
AIIMS, New Delhi |
Department of
Dermatology and
Venereology, 2nd floor, RAK OPD AIIMS,
New Delhi, India
New Delhi
DELHI |
8423975276
sandeepgup640@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee, AIIMS, New 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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Rituximab plus short-term oral prednisolone |
Rituximab 200mg 2 dose 2weeks apart
Tapering doses of oral prednisolone starting from 0.5-1 mg/kg/day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with pemphigus vulgaris |
|
| ExclusionCriteria |
| Details |
1. Patients who have received rituximab in the last
1 year
2. Patients with known absolute contra-indications
to corticosteroids or rituximab
3. Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with complete remission (on/off therapy)
Proportion of patients with partial remission (on/off therapy)
Proportion of patients with relapse
Proportion of patients requiring rescue treatment
Mean time to disease control
Mean time to disease remission
Mean time to relapse
Time change to ABQOL scores
Proportion of patients with B-cell depletion and repopulation at different time points
Proportion of patients with treatment adverse effects
|
at 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
21/07/2024 |
| 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 Applicable |
| 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
|
Patients with a confirmed diagnosis of pemphigus vulgaris (on biopsy or ELISA) will be recruited in the study as per the eligibility criteria after an informed consent (Annexures 1 and 2). Detailed clinical history and examination will be recorded in a pre-structured proforma (Annexure 3). Baseline pemphigus disease area index (Annexure 4) and ABQOL score (Annexure 5), will be recorded to assess the pemphigus severity and impact on quality-of-life. Patients will be treated with oral prednisolone and ultra-low dose rituximab protocol (200mg on day 0 and 14) after the standard pre-treatment evaluation. Patients will be followed up at 2 weeks, 1, 3, 6 and 12 months after the first dose of rituximab or until clinical relapse off treatment, whichever is earlier. A 5ml venous blood sample will be collected at day 0 (before rituximab administration) and at every follow-up visit for flow cytometric evaluation of peripheral B-cell counts. PDAI, ABQOL, scores will be recorded at day 0 and at all follow-up visits.
Treatment protocol Patients will be premedicated with hydrocortisone (100 mg), pheniramine maleate (8 mg), and paracetamol (1 g) intravenously 30 minutes prior to infusion. Injection rituximab (200 mg) in 200 ml of normal saline solution will be given over 2 hours and a second dose after 2 weeks. Patients will also be started on prednisolone (doses as per severity). As per the S2K guidelines. Mild pemphigus Prednisolone dose 0.5-1 mg/kg Moderate to severe pemphigus Prednisolone 1mg/kg |