Assessment of the utility of addition of oral immunosuppressant in pemphigus vulgaris PV patients receiving rituximab infusion RA protocol and oral prednisolone a pilot, randomized open-label trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- proportion of relapsing patients in rituximab infusion (RA protocol) with oral prednisolone group versus rituximab, oral prednisolone, and oral immunosuppressant group during 2 years study period
研究概览
简要总结
As per literature search, there is no prospective head-to-head randomized study to assess the utility of additional oral immunosuppressant in patients of pemphigus vulgaris receiving the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule
Research question: Does the addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule, offer additional benefit in terms of clinical and immunological efficacy in PV
Research hypothesis: The addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule, offers additional benefit in terms of clinical and immunological efficacy
Null hypothesis: The addition of an oral immunosuppressant to the regimen of rituximab infusion (RA protocol) and oral prednisolone in tapering schedule does not offer additional benefit in terms of clinical and immunological efficacy in PV
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting confirmed patients of active mucocutaneous PV of any severity, aged 18-70 years, of any gender, which are planned for rituximab therapy and admitted to the dermatology ward and daycare center, will be recruited.
排除标准
- •Pregnant and lactating women.
结局指标
主要结局
proportion of relapsing patients in rituximab infusion (RA protocol) with oral prednisolone group versus rituximab, oral prednisolone, and oral immunosuppressant group during 2 years study period
时间窗: baseline, 3months, remission, relapse
次要结局
- To compare the time to disease relapse between the two groups(2 years)
研究者
Dr Shreya K
MD DNB Department of dermatology, All India Institute of medical sciences, New Delhi