| CTRI Number |
CTRI/2020/06/025819 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
11/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non- interventional Observational safety study |
| Study Design |
Other |
|
Public Title of Study
|
A Observational non-interventional Post Marketing Surveillance (PMS) Study of RituxiRelTM RN(Rituximab)in Patients with Pemphigus Vulgaris |
|
Scientific Title of Study
|
A Prospective Multi-centre, Noninterventional,observational Post Marketing Surveillance (PMS) Study of RituxiRelTM RN(Rituximab) to Evaluate long-term safety in Patients with Pemphigus Vulgaris in Routine Clinical Practice |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RLS/PMS/2019/01: Version 1.0, Dated: 15 April 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Naik |
| Designation |
Head PV |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
DALC,R-282,TTC Area of MIDC ,Thane Belapur Road,Rabale,Navi Mumbai
Mumbai
MAHARASHTRA
400701
India |
| Phone |
8433707497 |
| Fax |
|
| Email |
manoj.naik@relbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Naik |
| Designation |
Head PV |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
DALC,R-282,TTC Area of MIDC ,Thane Belapur Road,Rabale,Navi Mumbai
Mumbai
MAHARASHTRA
400701
India |
| Phone |
8433707497 |
| Fax |
|
| Email |
manoj.naik@relbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Naik |
| Designation |
Head PV |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
DALC,R-282,TTC Area of MIDC ,Thane Belapur Road,Rabale,Navi Mumbai
Mumbai
MAHARASHTRA
400701
India |
| Phone |
8433707497 |
| Fax |
|
| Email |
manoj.naik@relbio.com |
|
|
Source of Monetary or Material Support
|
| Reliance Life Sciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Reliance Life Sciences Pv Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre R282 TTC Area of MIDC Thane Belapur Road,Rabale,Navi Mumbai 400701 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sharmila Patil |
Dy Patil Medical college and Hospital |
1st Floor, Building A, Department of Dermatology, Dy Patil Medical college and Hospital, Navi Mumbai-400706
Mumbai
MAHARASHTRA |
9821350217
drsharmilapatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC D.YPATIL MEDICAL COLLEGE NAVI MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patient inclusion will be sole decision of the Dermatologists according to his routine
practice. Minimum inclusion criteria clinically required can be as follows which will be at solediscretion of the Dermatologists.
Adults (18 through 70 years of age) with clinically-documented diagnosis of moderate to
severe Pemphigus vulgaris |
|
| ExclusionCriteria |
| Details |
Pregnant women, nursing mothers or a planned pregnancy within 18 months,Allergy to rituximab and any of the excipients of RituxiRelTM RN (rituximab), Active TB. Also excluded are patients who have evidence of latent TB [evidence of tuberculosisbased on chest X rays, QuantiFERON®-TB Gold test and other TB tests performed during screening]. Also excluded are patients with opportunistic infections including, but not limited to,evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or typical mycobacterial infection, etc., within the previous 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All adverse events (AEs) will be recorded and reported during all the follow up visits. All serious ADRs, including infections and malignancy,also occurrence of immediate or late infections, especially tuberculosis, Hepatitis, pneumonia, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, and sepsis and to specific important ADRs that included malignant neoplasm, demyelination, congestive heart failure, injection site reaction, and lupus. |
All adverse events (AEs) will be recorded and reported during all the follow up visits at 1 month for one year followed by every 3 months for the 2nd year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All adverse events (AEs) will be recorded and reported during all the follow up visits. All serious ADRs, including infections and malignancy,also occurrence of immediate or late infections, especially tuberculosis, Hepatitis, pneumonia, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, and sepsis and to specific important ADRs that included malignant neoplasm, demyelination, congestive heart failure, injection site reaction, and lupus. |
Every month follow up of safety parameters upto 1 year and then every 3 months upto 2nd year all safety parameters identified by physician will be recorded |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/06/2021 |
| 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)?
|
|
Brief Summary
|
The proposed Non-interventional observational Post Marketing Surveillance (PMS) Study of RituxiRelTM RN (Rituximab) to Evaluate Safety in Patients with moderate to severe pemphigus vulgaris in Routine Clinical Practice,to further evaluate the long term safety up to 2 years to consolidate the safety data. Total 100 patients with moderate to severe pemphuigus vulgaris who are prescribed RituxiRelTM RN (rituximab) will be considered in the study and will be administered two-1000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids as per routine practice
|