| CTRI Number |
CTRI/2019/01/017157 [Registered on: 18/01/2019] Trial Registered Prospectively |
| Last Modified On: |
16/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision between immunomodulator drug (rituximab) and immunosuppressant drug (steroids) versus only steroids in blistering disorder of skin |
|
Scientific Title of Study
|
Randomized controlled trial to compare the efficacy and safety of Rituximab infusion with systemic steroids versus only systemic steroids in Pemphigus group of disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hinal Jasvantbhai Prajapati |
| Designation |
1st year resident MD Dermatology |
| Affiliation |
GMERS Medical College and Hospital |
| Address |
A-19, Samtva Bunglows , near o7 club, at Shela
Ahmedabad
Room no. 202, OPD block A,
GMERS medical college and hospital, Sola, Ahmedabad.
380061
Ahmadabad
GUJARAT
380058
India |
| Phone |
8141133101 |
| Fax |
|
| Email |
prajapati.hinal93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krina Bharat Patel |
| Designation |
Professor and Head Of The Department |
| Affiliation |
GMERS Medical College and Hospital |
| Address |
Room no. 205, skin OPD, Block A, GMERS medical college and hospital, Sola, Ahmedabad.
Room no. 205, skin OPD, Block A, GMERS medical college and hospital, Sola, Ahmedabad.
Ahmadabad
GUJARAT
380061
India |
| Phone |
8141133101 |
| Fax |
|
| Email |
drkbpatel66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hinal Jasvantbhai Prajapati |
| Designation |
1st year resident MD Dermatology |
| Affiliation |
GMERS Medical College and Hospitall |
| Address |
GMERS medical college and hospital, Sola, Ahmedabad.
Ahmadabad
GUJARAT
380061
India |
| Phone |
8141133101 |
| Fax |
|
| Email |
prajapati.hinal93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Association of Dermatologist, Venereologist and Leprologist |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College and Hospital Sola |
| Address |
GMERS Medical College and Hospital, near Gujarat Highcourt, Sola
Ahmedabad 380061 |
| 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 |
| Hinal Prajapati |
GMERS Medical College and Hospital |
Room no. 202, dermatology OPD, block A, GMERS Medical College and Hospital, near Gujarat Highcourt, Sola
Ahmadabad
GUJARAT |
8141133101
prajapati.hinal93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, G.M.E.R.S Medical College and Civil Hospital, Sola, Ahmedabad |
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 and Systemic Steroids Versus only Systemic Steroids |
Rituximab is a chimeric monoclonal antibody that targets the CD20 molecule on B-cells.
IT IS FDA APPROVED IN MODERATE TO SEVERE PEMPHIGUS SINCE JUNE,2018.
Pulsed corticosteroids have been used successfully for the management of pemphigus. However, prolonged use of glucocorticoids may be associated with adverse effects and some patients show a poor response to conventional therapy. Biologics have shown a promising role in such cases; however, there is limited data from the Indian subcontinent.
Protocol for Rituximab :
➢ Seperate IV line
➢ Pre medications before 30 minutes of giving rituximab infusion:
Inj. Dexona 2cc IV
Inj. Avil 2cc IV
Tablet PCM 500mg
➢ Inj Rituximab (500mg) in 200 ml NS IV slowly
5 drops / min for 30 min
10 drops / min for 30 min
15 to 20 drops / min for rest.
To be completed in 4-6 hours. |
| Comparator Agent |
Systemic corticosteroids |
Initial dose of systemic steroids will be 60-160 mg(as per required). Corticosteroids dose will be gradually tapered 10-20 mg/week (as per requirement).Along with systemic therapy topical treatment will be given to the patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of above 18 years and of any gender , who willing to sign written informed consent. |
|
| ExclusionCriteria |
| Details |
Any patient with active bacterial, viral, invasive fungal infections.
HIV reactive patients.
Any haematological dyscrasia/ Bleeding tendency.
Patients with history of any severe drug reaction in past.
Patients with metabolic disturbances, cardiac disorders.
Pregnancy and lactation.
Patients or relatives – not willing to sign written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we will evaluate for cumulative dose of systemic steroids & time require to reach minimum dose (10 mg prednisolone daily) in each patients after 4 months |
Patients will be followed up: Weekly for 1 month Fortnightly for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study any side effects in both groups. |
From initiation of treatment to 4 months |
|
|
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)
|
21/01/2019 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pemphigus is a rare, life-threatening autoimmune disease. If not treated well it ends up with fatality. Systemic corticosteroids alone has to give for longer periods , which is associated with many adverse effect & some patients show poor response to it. So I will conduct this study to prove better impact of rituximab compare toconventional treatment which decreases need for steroids. |