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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
April 7, 2008
April 11, 2008
October 28, 2016
December 22, 2016
March 13, 2017
January 2008
July 2011   (Final data collection date for primary outcome measure)
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.
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00656656 on ClinicalTrials.gov Archive Site
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.
Side-effects of Treatment [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pemphigus
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.

Immunoadsorption/Dexamethasone/Rituximab
Intervention: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00656656
Pemphigus-Luebeck
Yes
Not Provided
Plan to Share IPD: No
Michael Kasperkiewicz, University of Luebeck
University of Luebeck
Not Provided
Principal Investigator: Detlef Zillikens, MD Department of Dermatology, University of Luebeck
University of Luebeck
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP