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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pemphigus Disease

Intervention / Treatment
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* Drug: General Corticotherapy
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br> | Drug: Rituximab<br>* 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,<br>|
| Active Comparator: Corticotherapy<br>General Corticotherapy | Drug: General Corticotherapy<br>* 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,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corticothérapy, Rituximab, therapeutic efficacity, therapeutic tolerance