Therapeutic efficacy of ultra-low dose rituximab in pemphigus vulgaris
Phase 2
- Conditions
- Health Condition 1: L100- Pemphigus vulgaris
- Registration Number
- CTRI/2024/07/070465
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult patients with pemphigus vulgaris
Exclusion Criteria
1. Patients who have received rituximab in the last
1 year
2. Patients with known absolute contra-indications
to corticosteroids or rituximab
3. Pregnant and lactating females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with complete remission (on/off therapy) <br/ ><br>Proportion of patients with partial remission (on/off therapy) <br/ ><br>Proportion of patients with relapse <br/ ><br>Proportion of patients requiring rescue treatment <br/ ><br>Mean time to disease control <br/ ><br>Mean time to disease remission <br/ ><br>Mean time to relapse <br/ ><br>Time change to ABQOL scores <br/ ><br>Proportion of patients with B-cell depletion and repopulation at different time points <br/ ><br>Proportion of patients with treatment adverse effects <br/ ><br>Timepoint: at 6 months and 12 months
- Secondary Outcome Measures
Name Time Method ilTimepoint: Not applicable