|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT00656656 |
|
Date of registration:
|
07/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
|
|
Scientific title:
|
Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab |
|
Date of first enrolment:
|
January 2008 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00656656 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Detlef Zillikens, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Dermatology, University of Luebeck |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pemphigus
|
|
Intervention(s)
|
|
Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
|
|
Primary Outcome(s)
|
|
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
[Time Frame: up to 43 months]
|
|
Secondary Outcome(s)
|
|
Number of Patients Who Experienced Side-effects of Treatment
[Time Frame: up to 43 months]
|
|
Secondary ID(s)
|
|
Pemphigus-Luebeck
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|