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

November 3, 2008
June 22, 2012
July 2009
December 2013   (final data collection date for primary outcome measure)
Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00784589 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus
Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pemphigus Disease
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,
Experimental: Rituximab
Intervention: Drug: General Corticotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2016
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Pascal JOLY, Professor (33)232888990 pascal.joly@chu-rouen.fr
Contact: philippe MUSETTE, Professor (33)232888990 philippe.musette@chu-rouen.fr
France
 
NCT00784589
2008/068/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Pascal JOLY, Professor Clinique Dermatologique - Hôpitaux de Rouen
University Hospital, Rouen
June 2012

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