| CTRI Number |
CTRI/2020/10/028675 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
13/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify if there are any clinical or immunological markers that can help us predict disease relapse in a patient. This knowledge can help the physicians to decide when to administer the maintenance treatment to prevent clinical relapse. |
|
Scientific Title of Study
|
Clinical and immunological factors predicting relapse in patients with pemphigus
treated with rituximab: A prospective cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Gupta |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 4068A, Department of Dermatology and Venereology, 4th
Floor, All India Institute of Medical Sciences, New Delhi
ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
011-26594985 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Gupta |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 4068A, Department of Dermatology and Venereology, 4th
Floor, All India Institute of Medical Sciences, New Delhi
ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
011-26594985 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhuja |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
#4070, Department of Dermatology office, All India Institute of Medical Sciences, New Delhi
South
DELHI
110049
India |
| Phone |
8897056554 |
| Fax |
|
| Email |
drsindhu.t@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi |
| 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 Vishal Gupta |
All India Institute of Medical Sciences |
D1 ward, Department of Dermatology, Ansari Nagar, New Delhi
South
DELHI |
011-26594985
doctor.vishalgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L100||Pemphigus vulgaris, (2) ICD-10 Condition: L102||Pemphigus foliaceous, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with confirmed pemphigus vulgaris or foliaceus treated with RTX- RA protocol.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have received RTX cycles in the preceding one year.
2. Patients with other concomitant autoimmune diseases.
3. Pregnant and lactating patients.
4. Patients who cannot come for follow up visits for at least 18 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of the changing trends of anti-dsg1, anti-dsg3, and anti-AchR (M3) antibody values between patients who relapse and who do not relapse.
2. Comparison of changing trends of CD 19+ and CD19+27+ B cells between relapsing and non-relapsing patients.
3. Comparison of baseline clinical parameters between relapsing and non-relapsing during the first two years after the initial cycle of rituximab.
|
Baseline, 3, 6, 9, 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of baseline immunological and clinical parameters between patients who experience disease flare and those who do not at the end of first month.
|
Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/11/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pemphigus is a potentially life-threatening autoimmune blistering disease. Treatment modalities include systemic corticosteroids, immunosuppressive agents (cyclophosphamide, azathioprine, mycophenolate mofetil etc) and rituximab (anti-CD20 monoclonal antibody). Rituximab is now recommended as one of the first-line treatments of pemphigus. However, relapses are common with all these therapies. Relapse rates with rituximab have been estimated at 2%, 14% and 40% at 6 months, 12 months and overall, respectively. The time to relapse after treatment with rituximab ranges from 6-24 months. Maintenance doses of rituximab, if can be given before the clinical relapse, can help prolong the disease-free remission period. Identification of factors that may predict the relapse can guide early intervention, the timing of maintenance dose, and decrease morbidity. There are only a few previous studies on this subject area, and have shown largely conflicting results. Our study aims to identify the clinical and immunological factors predicting relapse in patients with pemphigus treated with rituximab.
|