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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00784589
First received: November 3, 2008
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pemphigus Disease
 Drug: General Corticotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus

Resource links provided by NLM:

MedlinePlus related topics: Pemphigus Steroids
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: July 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab 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,

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784589

Contacts
Contact: Pascal JOLY, Professor (33)232888990 pascal.joly@chu-rouen.fr
Contact: philippe MUSETTE, Professor (33)232888990 philippe.musette@chu-rouen.fr

Locations
France
CHU de Rouen - Hôpitaux de Rouen Recruiting
Rouen, Seine Maritime, France, 76031
Contact: Helene , LAPEYRE     (33)232888990     helene.lapeyre@chu-rouen.fr    
Sub-Investigator: Sophie DUVERT LEHAMBRE, Doctor            
Principal Investigator: Pascal JOLY, Professor            
Sub-Investigator: Philippe MUSETTE, Professor            
Sub-Investigator: helene LAPEYRE, Doctor            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pascal JOLY, Professor Clinique Dermatologique - Hôpitaux de Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00784589     History of Changes
Other Study ID Numbers: 2008/068/HP
Study First Received: November 3, 2008
Last Updated: June 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Corticothérapy
Rituximab
therapeutic efficacity
therapeutic tolerance

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013