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

Phase 3

Completed

• Conditions: Pemphigus Disease
• Interventions: Drug: General Corticotherapy; Drug: Rituximab

• Registration Number: NCT00784589
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Study Start: 2009-07
• Primary Completion: 2013-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticotherapy	General Corticotherapy	General Corticotherapy
Rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment	2 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment	6 months

Trial Locations

Locations (1)

CHU de Rouen - Hôpitaux de Rouen; 🇫🇷 Rouen, Seine Maritime, France