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Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656656
First Posted: April 11, 2008
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Kasperkiewicz, University of Luebeck
  Purpose
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
Pemphigus Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Michael Kasperkiewicz, 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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656656


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

Responsible Party: Michael Kasperkiewicz, Dermatologist, University of Luebeck
ClinicalTrials.gov Identifier: NCT00656656     History of Changes
Other Study ID Numbers: Pemphigus-Luebeck
First Submitted: April 7, 2008
First Posted: April 11, 2008
Results First Submitted: October 28, 2016
Results First Posted: December 22, 2016
Last Update Posted: March 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Kasperkiewicz, University of Luebeck:
pemphigus
rituximab
immunoadsorption
dexamethasone
treatment
management

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Rituximab
Azathioprine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
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
Antimetabolites, Antineoplastic
Immunosuppressive Agents