| CTRI Number |
CTRI/2024/09/074507 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study, I will compare the role of Rituximab 2000 mg vs Rituximab 200 mg in assessing the effectiveness in the management of Pemphigus |
|
Scientific Title of Study
|
Comparison of efficacy of Rituximab, standard rheumatoid arthritis protocol (2 grams) vs ultra-low dose (200 mg) in the management of Pemphigus: A Randomized Controlled 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 Raushan Kumar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room no. 105, Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, OPD 1st floor, Division 1A block
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8447032095 |
| Fax |
|
| Email |
raushan0507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room no. 111, Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, OPD 1st floor, Division 1A block
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9968024250 |
| Fax |
|
| Email |
saurabhdoc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raushan Kumar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room no. 105, Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, OPD 1st floor, Division 1A block
Room no- 130, Ground floor, PG hostel, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8447032095 |
| Fax |
|
| Email |
raushan0507@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS JODHPUR, Basni, Jodhpur, Rajasthan, Pincode- 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
Room no-130, PG Hostel, Department of Dermatology, Venereology and Leprology, AIIMS Jodhpur, Basni, 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Raushan Kumar |
All India Institute of Medical Sciences, Jodhpur |
Room no-130, PG Hostel, Department of Dermatology, Venereology and Leprology, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
8447032095
raushan0507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Jodhpur |
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 |
Efficacy of Rituximab, 1 gram 2 weeks apart in the management of Pemphigus. Randomized Controlled Trial |
Patients diagnosed with Pemphigus based on clinical features, Tzanck smear,
Histopathological examination ± Direct Immunofluorescence findings will be included in
the study. The participants will be divided into 2 groups A and B. Group A will receive
Standard dose Rituximab, RA protocol 2000 mg (2 infusions of 1000 mg at 2 weeks apart) by intravenous route 2 times 14 days apart and
Group B will receive ultra low Rituximab 200 mg (2 infusions of 100 mg at 2 weeks apart) by intravenous route 2 doses 14 days apart. Efficacy
and safety profile in two groups will be measured. Study will be approximately of 18
months. Research question is whether ultra-low dose Rituximab (200 mg) is efficacious in
the management of Pemphigus. Aim of the study is to compare the efficacy and safety
profile upon administration of Rituximab, RA Protocol (2000 mg) vs ultra low dose (200
mg). Our Primary Objective is to compare the efficacy between 2 groups based on Clinical
(complete remission on minimal therapy, Time to complete remission) and Laboratory
parameters (trends of peripheral blood B cell marker CD19 in patients). Our secondary
objectives are to do comparison of relapse, safety profile and cost analysis between 2
groups. Patients diagnosed with Pemphigus based on clinical features, Tzanck smear,
Histopathological examination ± Direct Immunofluorescence findings will be included in
the study. Patients having Rituximab infusion within 9 months, Dexamethasone-
Cyclophosphamide pulse therapy within 3 months, steroid sparing adjuvant
immunosuppressants use within 4 weeks, paraneoplastic pemphigus, pregnancy or
lactation, any active infections (viral hepatitis, HIV, TB, Sepsis), known hypersensitivity to
any study molecule, cardiac arrythmias will be excluded from the study. Total duration of intervention- 18 months. We are expecting that Ultra-low dose Rituximab (2 infusions of 100 mg at 2 weeks apart)
will provide good results. |
| Intervention |
Efficacy of Rituximab, 100 mg at 2 weeks apart in the management of Pemphigus: Randomized Controlled Trial |
Patients diagnosed with Pemphigus based on clinical features, Tzanck smear,
Histopathological examination ± Direct Immunofluorescence findings will be included in
the study. The participants will be divided into 2 groups A and B. Group A will receive
Standard dose Rituximab, RA protocol 2000 mg (2 infusions of 1000 mg at 2 weeks apart) by intravenous route 2 times 14 days apart and
Group B will receive ultra low Rituximab 200 mg (2 infusions of 100 mg at 2 weeks apart) by intravenous route 2 doses 14 days apart. Efficacy
and safety profile in two groups will be measured. Study will be approximately of 18
months. Research question is whether ultra-low dose Rituximab (200 mg) is efficacious in
the management of Pemphigus. Aim of the study is to compare the efficacy and safety
profile upon administration of Rituximab, RA Protocol (2000 mg) vs ultra low dose (200
mg). Our Primary Objective is to compare the efficacy between 2 groups based on Clinical
(complete remission on minimal therapy, Time to complete remission) and Laboratory
parameters (trends of peripheral blood B cell marker CD19 in patients). Our secondary
objectives are to do comparison of relapse, safety profile and cost analysis between 2
groups. Patients diagnosed with Pemphigus based on clinical features, Tzanck smear,
Histopathological examination ± Direct Immunofluorescence findings will be included in
the study. Patients having Rituximab infusion within 9 months, Dexamethasone-
Cyclophosphamide pulse therapy within 3 months, steroid sparing adjuvant
immunosuppressants use within 4 weeks, paraneoplastic pemphigus, pregnancy or
lactation, any active infections (viral hepatitis, HIV, TB, Sepsis), known hypersensitivity to
any study molecule, cardiac arrythmias will be excluded from the study. Total duration of intervention- 18 months. We are expecting that Ultra-low dose Rituximab (2 infusions of 100 mg at 2 weeks apart)
will provide good results. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cases of Pemphigus (confirmed as Pemphigus on clinical features + Tzanck smear +
Histopathological features± Direct immunofluorescence findings) |
|
| ExclusionCriteria |
| Details |
1.Rituximab Infusion within past nine months
2.Dexamethasone- Cyclophosphamide Pulse therapy within past three months
3.Steroid sparing adjuvant immunosuppressants use within past four weeks
4.Paraneoplastic Pemphigus
5.Pregnancy or breastfeeding
6.Any known active systemic/ local infusion site local infections (Tuberculosis, HIV, viral
hepatitis, Sepsis)
7.Any known hypersensitivity to the study molecules
8.Any contraindications to the study molecules |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Rituximab 2 gm vs Rituximab 200 mg in the management of Pemphigus in terms of:-
1.Based on PDAI and ABSIS scores
2. Based on VAS scale
3. Flow cytometric analysis of peripheral B cell marker CD19 |
Baseline, 1 month, 3 month, 6 month and 9 months post Rituximab infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Rituximab 2 gm vs Rituximab 200 mg in the management of Pemphigus in terms of:-
1. Relapse rate shall be calculated for each group (immunological and clinical)
2. Side effect profile
3. Cost analysis
|
Baseline, 1 month, 3 month, 6 month and 9 months post Rituximab infusion |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/10/2024 |
| 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="1"
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 diagnosed with Pemphigus based on clinical features, Tzanck smear, Histopathological examination ± Direct Immunofluorescence findings will be included in the study. The participants will be divided into 2 groups A and B. Group A will receive Standard dose Rituximab, RA protocol (2 infusions of 1000 mg at 2 weeks apart) and Group B will receive ultra low Rituximab (2 infusions of 100 mg at 2 weeks apart). Efficacy and safety profile in two groups will be measured. Study will be approximately of 18 months. Research question is whether ultra-low dose Rituximab (200 mg) is efficacious in the management of Pemphigus. Aim of the study is to compare the efficacy and safety profile upon administration of Rituximab, RA Protocol (2000 mg) vs ultra low dose (200 mg). Our Primary Objective is to compare the efficacy between 2 groups based on Clinical (complete remission on minimal therapy, Time to complete remission) and Laboratory parameters (trends of peripheral blood B cell marker CD19 in patients). Our secondary objectives are to do comparison of relapse, safety profile and cost analysis between 2 groups. Patients diagnosed with Pemphigus based on clinical features, Tzanck smear, Histopathological examination ± Direct Immunofluorescence findings will be included in the study. Patients having Rituximab infusion within 9 months, Dexamethasone- Cyclophosphamide pulse therapy within 3 months, steroid sparing adjuvant immunosuppressants use within 4 weeks, paraneoplastic pemphigus, pregnancy or lactation, any active infections (viral hepatitis, HIV, TB, Sepsis), known hypersensitivity to any study molecule, cardiac arrythmias will be excluded from the study. We are expecting that Ultra-low dose Rituximab (2 infusions of 100 mg at 2 weeks apart) will provide good results. |