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Trial record 10 of 41 for:    pemphigus

Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

This study has been completed.
Information provided by (Responsible Party):
Michael Kasperkiewicz, University of Luebeck Identifier:
First received: April 7, 2008
Last updated: January 31, 2017
Last verified: January 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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: 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:
  • Number of Patients Who Experienced Side-effects of Treatment [ Time Frame: up to 43 months ]
    Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.

Enrollment: 23
Study Start Date: January 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immunoadsorption/Dexamethasone/Rituximab 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)
Sexes Eligible for Study:   All
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: Michael Kasperkiewicz, Dermatologist, University of Luebeck Identifier: NCT00656656     History of Changes
Other Study ID Numbers: Pemphigus-Luebeck
Study First Received: April 7, 2008
Results First Received: October 28, 2016
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

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 May 24, 2017