drugset / Trial / NCT00626678

Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

NCT00626678

Phase 2 Completed 48 enrolled Tehran University of Medical Sciences
RandomizedParallel-groupTriple-blindTreatment

Summary

Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality. The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs. The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Timeline

Start
2008-01
Primary completion
2008-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 2.5 mg/kg Oral
Background Prednisone Other / unclassified 7.5 mg Oral

Indications