A Observational non-interventional Post Marketing Surveillance (PMS) Study of RituxiRelTM RN(Rituximab)in Patients with Pemphigus Vulgaris

Not Applicable

Not yet recruiting

Conditions: Other specified local infections of the skin and subcutaneous tissue,

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**

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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, QuantiFERONÂ®-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.

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Locations (1): Dy Patil Medical college and Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Dy Patil Medical college and Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Sharmila Patil
Principal investigator
9821350217
drsharmilapatil@gmail.com