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Clinical Trials/CTRI/2020/06/025819
CTRI/2020/06/025819
Not yet recruiting
Phase 4

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

Reliance Life Sciences Pv Ltd0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Sponsor
Reliance Life Sciences Pv Ltd
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Reliance Life Sciences Pv Ltd

Eligibility Criteria

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, 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

Outcomes

Primary Outcomes

Not specified

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