Health Condition 1: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: IV cyclophosphamide pulse therapy: Monthly IV(intravenous) cyclophosphamide at a dose of 0.5 to 1.0 g/m2 of body surface area in 250 mL of isotonic sodium chloride solution ,infused ove
Sponsors
AIIMS , New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a clinical and laboratory diagnosis of pemphigus vulgaris irrespective of gender. Patient with pemphigus vulgaris who received rituximab at least 6 months back as per EDF guidelines and is currently in remission. Patient with moderate to severe disease, PDAI more than 15.
Exclusion criteria
Exclusion criteria: Patients with pemphigus vulgaris who fail to achieve remission with rituximab. Patients with localized or mild disease, PDAI is less than 15. Patient with only mucosal lesions. Patients who have achieved remission with rituximab but are on any other alternate adjuvant therapy. Patients did not give consent to be part of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the difference in relapse rate of disease in patient receiving IV Cyclophosphamide pulse versus those not receiving any adjuvant therapy following remission with Rituximab.Timepoint: patient will be assessed at baseline at 3 months , 6 months, 9 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare adverse effect profile both cohortsTimepoint: 3 monthly follow up;Comparison between duration and severity of relapse in patient receiving cyclophosphamide pulse therapy post first cycle of rituximab and those receiving it after multiple cycles.Timepoint: 3 monthly follow up;Correlation between no. of rituximab cycles received earlier and duration of remission following that.Timepoint: 3 monthly follow up;Difference in severity and time of relapse in each group.Timepoint: 3 monthly follow up | — |
Countries
India
Contacts
Public ContactKaushal k Verma
AIIMS HOSPITAL
Outcome results
None listed