Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus (Rituximab 3)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00784589

First received: November 3, 2008

Last updated: September 5, 2014

Last verified: September 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2008

Last Updated Date

September 5, 2014

Start Date ^ICMJE

July 2009

Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00784589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus

Official Title ^ICMJE

Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus

Brief Summary

Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients.

The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pemphigus Disease

Intervention ^ICMJE

Drug: General Corticotherapy

for patients with severe pemphigus : rituximab Arm : 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 1 month, then 0.3 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, then 0.1 mg/kg/d for 1 month general corticotherapy Arm : 1.5mg/kg/d for 1 month, then 1.25mg/kg/d for 1 month, then 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 3 months, then 0.3 mg/kg/d for 3 months, then 0.2 mg/kg/d for 4 months, then 0.1 mg/kg/d for 4 months, for patients with moderated pemphigus : rituximab Arm : 0.5mg/kg/d for 1 month, then 0.30 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, general corticotherapy Arm : 1mg/kg/d for 1 month, then 0.75mg/kg/d for 1 month, then 0.5mg/kg/d for 2 months, then 0.3 mg/kg/d for 2 months, then 0.2 mg/kg/d for 3 months, then 0.1 mg/kg/d for 3 months,

Study Arm (s)

Experimental: Rituximab

Intervention: Drug: General Corticotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2016

Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age >=18 and <= 80years
consent obtained from patient
effective female contraceptive method for women in procreate age
new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF)

Exclusion Criteria:

pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated
pregnant woman or nursing mother
woman able to have a baby and without contraception during the clinical trial period
age < 18 or > 80
karnovsky < 50%
serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
patient with depletion lymphocytic treatment in the next month
unstable angina or ischemic heart disease
cardiac insufficiency
cardiac rhythm trouble uncontrolled
positive HIV serology
positive hepatitis B and / or C serology
no consent

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00784589

Other Study ID Numbers ^ICMJE

2008/068/HP

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Rouen

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pascal JOLY, Professor

Clinique Dermatologique - Hôpitaux de Rouen

Information Provided By

University Hospital, Rouen

Verification Date

September 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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