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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

April 7, 2008
June 29, 2010
January 2008
September 2010   (final data collection date for primary outcome measure)
Number of patients achieving a short- and long-term remission of pemphigus [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00656656 on ClinicalTrials.gov Archive Site
Side-effects of treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5
September 2010
September 2010   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00656656
Pemphigus-Luebeck
Yes
Professor Detlef Zillikens, MD, Director, Department of Dermatology, University of Luebeck
University of Luebeck
Not Provided
Principal Investigator: Detlef Zillikens, MD Department of Dermatology, University of Luebeck
University of Luebeck
June 2010

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