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Completed

NCT Number: NCT00525616

Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Rouen, 76031, France

About this study

The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.

the main objects are :

  • to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
  • to avoid the use of corticosteroid in long time,
  • to evaluate duration of control disease and side effect with a single cycle of rituximab.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • immunodepression
  • neutrophil polynuclear in blood < 1.5 G/l and /or platelet blood concentration < 75G/l
  • positive HIV serology
  • positive hepatitis B and / or C serology
  • concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
  • no consentment
  • antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
  • antecedent of deep tissue infection occurred the previous year of inclusion

Treatment and study plan

Mabthera

Drug

Two IV perfusions of 1000mg at 15 days intervals

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.

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

Acronym: Rituximab2

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2007
Registry last updated
Apr 16, 2026

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.

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