The efficacy of rituximab for recalcitrant Pemphigus Vulgaris in the patients of Razi hospital from 2007 to 2011
Phase 2
- Conditions
- Pemphigus vulgaris.Pemphigus vulgaris
- Registration Number
- IRCT201111022704N2
- Lead Sponsor
- Vice-chancellor for Research of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients with Pemphigus Vulgaris who are candidates for rituximab (failure to respond or frequent recurrences under long-term (months to years) oral corticosteroids more than 10 mg daily with or without additional immunosuppressive therapy? or oral corticosteroids intolerance with or without short and long-term oral coricosteroids side effects)
Exclusion criterion were: pregnancy and breast feeding?history of sensitization to murine protein?hepatitis B cariers?cardiac arrhythmias & angina pectoris?high tumor burden?active infections
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic effect(new blisters per day, Nikolsky’s sign and epithelialization over the denuded surfaces). Timepoint: weekly for 1 month and then monthly after injecting rituximab. Method of measurement: clinical examination.;The dose of oral prednisolone. Timepoint: prior to treatment, next 3 months, next 6 months and the final in the last visit. Method of measurement: mg per day.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: weekly for 1 month and then monthly after injecting rituximab. Method of measurement: clinical examination.