Effect of Anti CD20 in Pemphigus Desease
Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT00213512
Collaborator
(none)
22
1
64
0.3
Study Details
Study Description
Brief Summary
to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).
Study Start Date
:
Jun 1, 2003
Actual Primary Completion Date
:
Jun 1, 2006
Actual Study Completion Date
:
Oct 1, 2008
Outcome Measures
Primary Outcome Measures
- primary end-point was the rate of CR three months after the last infusion of Rituximab []
Secondary Outcome Measures
- secondary end-points were : []
- rate of CR during the study period []
- time from the start of Rituximab to CR []
- number and length of time to relapses []
- treatment tolerance []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
age>18
-
pemphigus corticoresistant
-
pemphigus cortico dependant
-
contre-indications : systémic steroids
Exclusion Criteria:
-
age < 18
-
cardiopathie
-
pregnant woman
-
absence contraception
-
no consentment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UH-Rouen | Rouen | Seine maritime | France | 76000 |
Sponsors and Collaborators
- University Hospital, Rouen
Investigators
- Principal Investigator: pascal Joly, MD-PHD, UH-Rouen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213512
Other Study ID Numbers:
- 2002/020/HP
First Posted:
Sep 21, 2005
Last Update Posted:
Jun 18, 2013
Last Verified:
Jun 1, 2013