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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Pemphigus Disease

Treatments: Drug: Rituximab; Drug: General Corticotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00784589

2008/068/HP

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Rituximab

Experimental group

Treatment:

Drug: Rituximab

Corticotherapy

Active Comparator group

Description:

General Corticotherapy

Treatment:

Drug: General Corticotherapy