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Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Kasperkiewicz, University of Luebeck
ClinicalTrials.gov Identifier:
NCT00656656
First received: April 7, 2008
Last updated: January 31, 2017
Last verified: January 2017
Results First Received: October 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Pemphigus
Intervention: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Immunoadsorption/Dexamethasone/Rituximab

Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil

Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 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 initially every 3 weeks

Azathioprine: 2.5 mg/kg body weight daily p.o.

Mycophenolate mofetil 2 g/d p.o.


Participant Flow:   Overall Study
    Immunoadsorption/Dexamethasone/Rituximab
STARTED   23 
COMPLETED   23 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Immunoadsorption/Dexamethasone/Rituximab

Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil

Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 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 initially every 3 weeks

Azathioprine: 2.5 mg/kg body weight daily p.o.

Mycophenolate mofetil 2 g/d p.o.


Baseline Measures
   Immunoadsorption/Dexamethasone/Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      17  73.9% 
>=65 years      6  26.1% 
Age 
[Units: Years]
Mean (Full Range)
 55 
 (26 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  47.8% 
Male      12  52.2% 
Region of Enrollment 
[Units: Participants]
 
Germany   23 


  Outcome Measures
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1.  Primary:   Number of Patients Achieving a Short- and Long-term Remission of Pemphigus   [ Time Frame: up to 43 months ]

2.  Secondary:   Number of Patients Who Experienced Side-effects of Treatment   [ Time Frame: up to 43 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Dr. Detlef Zillikens
Organization: University of Lübeck
phone: +49-451-500-41500
e-mail: detlef.zillikens@uksh.de



Responsible Party: Michael Kasperkiewicz, University of Luebeck
ClinicalTrials.gov Identifier: NCT00656656     History of Changes
Other Study ID Numbers: Pemphigus-Luebeck
Study First Received: April 7, 2008
Results First Received: October 28, 2016
Last Updated: January 31, 2017