Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

University of Luebeck

Status and phase

Completed

Phase 2

Conditions

Pemphigus

Treatments

Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine

Study type

Interventional

Funder types

Other

Identifiers

NCT00656656

Pemphigus-Luebeck

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.

Exclusion criteria