This trial is active, not recruiting.

Condition pemphigus
Treatment combination of protein a immunoadsorption, rituximab, dexamethasone plus azathioprine
Phase phase 2
Sponsor University of Luebeck
Start date January 2008
End date September 2010
Trial size 5 participants
Trial identifier NCT00656656, Pemphigus-Luebeck


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Number of patients achieving a short- and long-term remission of pemphigus
time frame: 2 years

Secondary Outcomes

Side-effects of treatment
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
Principal investigator Detlef Zillikens, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Luebeck.