Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

NCT00656656 | Completed Phase 2 Results DMC

• 1 other identifier: Pemphigus-Luebeck
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

pemphigus; rituximab; immunoadsorption; dexamethasone; treatment; management

Outcome Measures

Primary Outcomes (1)

• Number of Patients Achieving a Short- and Long-term Remission of Pemphigus

  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.

  up to 43 months

Secondary Outcomes (1)

• Number of Patients Who Experienced Side-effects of Treatment

  up to 43 months

Study Arms (1)

Immunoadsorption/Dexamethasone/Rituximab

OTHER

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

Interventions

Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine 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.

Immunoadsorption/Dexamethasone/Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• General condition too poor to tolerate immunoadsorption treatment.
• Severe dementia or psychiatric disease.

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Department of Dermatology, University of Luebeck

Lübeck, Schleswig-Holstein, 23552, Germany

Location

MeSH Terms

Conditions

Pemphigus

Interventions

Rituximab; Dexamethasone; Azathioprine

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Prof. Dr. Detlef Zillikens
• Organization: University of Lübeck

detlef.zillikens@uksh.de

+49-451-500-41500

Study Officials

• Detlef Zillikens, MD

  Department of Dermatology, University of Luebeck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 13, 2017
• Results First Posted: December 22, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)