Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Phase 2

Completed

• Conditions: Pemphigus
• Interventions: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine

• Registration Number: NCT00656656
• Lead Sponsor: University of Luebeck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2016-10-28
• Results First Submitted QC: 2016-10-28
• Results First Posted: 2016-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunoadsorption/Dexamethasone/Rituximab	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus	up to 43 months	Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced Side-effects of Treatment	up to 43 months	Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.

Trial Locations

Locations (1)

Department of Dermatology, University of Luebeck; 🇩🇪 Luebeck, Schleswig-Holstein, Germany