CTRI/2020/06/025819尚未招募4 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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
排除标准
- •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
研究者
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