drugset / Trial / NCT00656656

Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

NCT00656656

Phase 2 Completed 23 enrolled University of Luebeck
NaSingle-groupOpen-labelTreatment

Summary

Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.

Timeline

Start
2008-01
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 100 mg Intravenous
Subject Rituximab Monoclonal antibody 1000 mg Intravenous
Background Azathioprine Small molecule 2.5 mg/kg Oral

Indications