Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

NCT00525616 | Completed Phase 3

• 1 other identifier: 2006/101/HP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

Conditions

Bullous Pemphigoid

Keywords

bullous pemphigoid; mabthera

Outcome Measures

Primary Outcomes (1)

• Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years.

  2 years

Secondary Outcomes (1)

• Adverse reactions will be estimated during all the period of this clinical trial

  3 years

Study Arms (1)

Rituximab

EXPERIMENTAL

Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .

Drug: Mabthera

Interventions

Mabthera DRUG

Two IV perfusions of 1000mg at 15 days intervals

Rituximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18 and \< 80
• karnofsky \>= 50%
• bullous pemphigoid clinical indication
• cortico-dependent bullous pemphigoid in relapse for the second time
• contraception used in female patient
• consent obtained from patient

You may not qualify if:

• localized bullous pemphigoid in relapse (\<400cm2)
• pemphigoid of pregnancy
• dermatosis with IgA
• pemphigoid with mucous damage
• 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%
• significant disease or uncontrolled disease
• serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
• patient with depletion lymphocytic treatment or with initial rituximab treatment
• unstable angina or ischemic heart disease
• cardiac insufficiency
• cardiac rhythm trouble uncontrolled
• evolutive infection

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital, Direction de la Recherche et de l'Innovation,

Rouen, 76031, France

Location

Related Publications (1)

• Berkani N, Joly P, Golinski ML, Colliou N, Lim A, Larbi A, Riou G, Caillot F, Bernard P, Bedane C, Delaporte E, Chaby G, Dompmartin A, Hertl M, Calbo S, Musette P. B-cell depletion induces a shift in self antigen specific B-cell repertoire and cytokine pattern in patients with bullous pemphigoid. Sci Rep. 2019 Mar 5;9(1):3525. doi: 10.1038/s41598-019-40203-7.

  PMID: 30837635 RESULT

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pascal JOLY, MD-PHD

  Clinique Dermatologique - Hôpital Charles Nicolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: September 6, 2007
• Study Start: December 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)