NCT00213512

Brief Summary

to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2013

Conditions

Pemphigus

Outcome Measures

Primary Outcomes (1)

  • primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcomes (5)

  • 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

Interventions

MabtheraDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\>18
  • pemphigus corticoresistant
  • pemphigus cortico dependant
  • contre-indications : systémic steroids

You may not qualify if:

  • age \< 18
  • cardiopathie
  • pregnant woman
  • absence contraception
  • no consentment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH-Rouen

Rouen, Seine maritime, 76000, France

Location

Related Publications (1)

  • Joly P, Mouquet H, Roujeau JC, D'Incan M, Gilbert D, Jacquot S, Gougeon ML, Bedane C, Muller R, Dreno B, Doutre MS, Delaporte E, Pauwels C, Franck N, Caux F, Picard C, Tancrede-Bohin E, Bernard P, Tron F, Hertl M, Musette P. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007 Aug 9;357(6):545-52. doi: 10.1056/NEJMoa067752.

    PMID: 17687130DERIVED

MeSH Terms

Conditions

Pemphigus

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • pascal Joly, MD-PHD

    UH-Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2003

Primary Completion

June 1, 2006

Study Completion

October 1, 2008

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)