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.
Investigators
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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