Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

• ClinicalTrials.gov Identifier: NCT00656656
• Recruitment Status: Completed
• First Posted: April 11, 2008
• Results First Posted: December 22, 2016
• Last Update Posted: March 13, 2017
• Sponsor: University of Luebeck
• Information provided by (Responsible Party): Michael Kasperkiewicz, University of Luebeck

Tracking Information

• First Submitted Date: April 7, 2008
• First Posted Date: April 11, 2008
• Results First Submitted Date: October 28, 2016
• Results First Posted Date: December 22, 2016
• Last Update Posted Date: March 13, 2017
• Study Start Date: January 2008
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2017)

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.

• Original Primary Outcome Measures (submitted: April 7, 2008): Number of patients achieving a short- and long-term remission of pemphigus [ Time Frame: 2 years ]

Current Secondary Outcome Measures (submitted: January 31, 2017)

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.

• Original Secondary Outcome Measures (submitted: April 7, 2008): Side-effects of treatment [ Time Frame: 2 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
• Official Title: Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pemphigus

Intervention

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.

Study Arms

Immunoadsorption/Dexamethasone/Rituximab

Intervention: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2016): 23
• Original Estimated Enrollment (submitted: April 7, 2008): 5
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00656656
• Other Study ID Numbers: Pemphigus-Luebeck
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael Kasperkiewicz, University of Luebeck
• Original Responsible Party: Professor Detlef Zillikens, MD, Director, Department of Dermatology, University of Luebeck
• Current Study Sponsor: University of Luebeck
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Detlef Zillikens, MD; Department of Dermatology, University of Luebeck

• PRS Account: University of Luebeck
• Verification Date: January 2017