Comparison Between Rituximab Treatment 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.

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Key information

Conditions

Pemphigus Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Rouen - Hôpitaux de Rouen

Rouen, Seine Maritime, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Corticotherapy

Drug

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

Drug

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,

Primary outcomes

Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment

Time frame: 2 years

Secondary outcomes

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

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: Rituximab 3

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2016
First posted: Nov 4, 2008
Registry last updated: Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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