Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Luebeck.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00656656
First received: April 7, 2008
Last updated: June 29, 2010
Last verified: June 2010
  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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Detlef Zillikens, MD, Director, Department of Dermatology, University of Luebeck
ClinicalTrials.gov 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:
pemphigus
rituximab
immunoadsorption
dexamethasone
treatment
management

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Rituximab
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014