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Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Luebeck.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Luebeck Identifier:
First received: April 7, 2008
Last updated: June 29, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab

Resource links provided by NLM:

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Number of patients achieving a short- and long-term remission of pemphigus [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side-effects of treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: January 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00656656

Department of Dermatology, University of Luebeck
Luebeck, Schleswig-Holstein, Germany, 23552
Sponsors and Collaborators
University of Luebeck
Principal Investigator: Detlef Zillikens, MD Department of Dermatology, University of Luebeck
  More Information

Responsible Party: Professor Detlef Zillikens, MD, Director, Department of Dermatology, University of Luebeck Identifier: NCT00656656     History of Changes
Other Study ID Numbers: Pemphigus-Luebeck 
Study First Received: April 7, 2008
Last Updated: June 29, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:

Additional relevant MeSH terms:
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antirheumatic Agents
Antimetabolites, Antineoplastic
Immunosuppressive Agents processed this record on December 08, 2016