Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

NCT ID: NCT00656656

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-07-31

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.

Conditions

Pemphigus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunoadsorption/Dexamethasone/Rituximab

Group Type: OTHER

Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Michael Kasperkiewicz

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Detlef Zillikens, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University of Luebeck

Locations

Department of Dermatology, University of Luebeck

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

Pemphigus-Luebeck

Identifier Type: -

Identifier Source: org_study_id