Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Pemphigus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00656656
• Other study ID #: Pemphigus-Luebeck
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 7, 2008
• Last updated: June 29, 2010
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: June 2010
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• General condition too poor to tolerate immunoadsorption treatment.

• Severe dementia or psychiatric disease.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pemphigus

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Dermatology, University of Luebeck	Luebeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients achieving a short- and long-term remission of pemphigus		2 years	No
Secondary	Side-effects of treatment		2 years	Yes