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

Pemphigus Disease Clinical Trial

— Rituximab 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784589
• Other study ID #: 2008/068/HP
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: June 13, 2017
• Start date: July 2009
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pemphigus
• Pemphigus Disease

Intervention

Drug:
• General Corticotherapy
for patients with severe pemphigus : 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 : 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,
• Rituximab
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 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,

Locations

Country	Name	City	State
France	CHU de Rouen - Hôpitaux de Rouen	Rouen	Seine Maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment		2 years
Secondary	Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment		6 months