NCT00656656

Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pemphigus

Interventions

Type	Name	Description
DRUG	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine	Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-04-11
• Last updated: 2017-03-13
• Results posted: 2016-12-22

Locations

1 site across 1 country: Germany