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Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial (LTFURITUX3)

Primary Purpose

Autoimmune Diseases

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rituximab
corticosteroids'therapy
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient included in the RITUXIMAB 3 study
  • Major patient who has read and understood the newsletter and signed the consent form

Exclusion Criteria:

  • Person deprived of liberty by an administrative or judicial decision
  • Person placed under the safeguard of justice
  • Person under tutorship or curators
  • Pregnant or lactating woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rituximab

    Standard corticosteroid

    Arm Description

    Rituximab in combination with reduced corticosteroids is administrated

    Standard corticosteroid is administrated

    Outcomes

    Primary Outcome Measures

    Evaluate the occurrence of long-term serious AEs and AEs in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
    Collect of SAE and AE
    Evaluate the long-term relapse rate in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
    Collect of relapses

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2018
    Last Updated
    December 27, 2018
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03790293
    Brief Title
    Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial
    Acronym
    LTFURITUX3
    Official Title
    Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial With Medico-economic Evaluation of the Treatment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by the production of IgG4 isotype autoantibodies (AC) directed mainly against two proteins involved in interkeratinocyte adhesion: desmoglein 1 (Dsg1 ) and desmoglein 3 (Dsg3) (1-3). The binding of auto-AC on these proteins disrupts their adhesion function, resulting in inter-keratinocyte dysjunction called "acantholysis" responsible for the formation of intraepidermal bubbles. Treatment of pemphigus is typically based on systemic corticosteroids. High doses are usually necessary because of the frequent cortico-resistance of the disease. In recent years, several studies have focused on the treatment of pemphigus with anti-CD20: rituximab. The "Ritux 3" study (NCT00784589), a randomized, multicentre, randomized, non-blind clinical trial involving 90 patients, found that the use of rituximab as first-line therapy in combination with short corticosteroid therapy was extremely effective and that cortisone sparing was thus obtained limited the occurrence of side effects of treatment. On the other hand, this study showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the maintenance of a high rate of complete remission up to the 3rd year of follow-up. Questions remain to explain the long-term action of rituximab, in particular that of the evolution of these auto-reactive B cells (specific DSG) away from lymphocyte reconstitution B, as well as the evolution of auto-AC. anti-DSG and total IgG CAs, so as to ensure that the disappearance of the auto-reactive compartment is not accompanied by a long-term overall immunosuppression (and therefore a possible risk of infection). The immunological changes induced in the long term as well as the precise mechanism of action of these treatments and particularly rituximab which allows a complete remission 5 years after treatment in many patients remain little known.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autoimmune Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients included and treated in the RITUXIMAB 3 study (NCT00784589): Rituximab in combination with reduced corticosteroids Standard corticosteroid
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rituximab
    Arm Type
    Experimental
    Arm Description
    Rituximab in combination with reduced corticosteroids is administrated
    Arm Title
    Standard corticosteroid
    Arm Type
    Active Comparator
    Arm Description
    Standard corticosteroid is administrated
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Intervention Description
    Patient was enrolled into the RITUXIMAB 3 study in the arm Rituximab in association with low corticosteroids'therapy
    Intervention Type
    Drug
    Intervention Name(s)
    corticosteroids'therapy
    Intervention Description
    Patient was enrolled into the RITUXIMAB 3 study in the arm Patient was enrolled into the RITUXIMAB 3 study in the arm standard corticosteroid
    Primary Outcome Measure Information:
    Title
    Evaluate the occurrence of long-term serious AEs and AEs in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
    Description
    Collect of SAE and AE
    Time Frame
    1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study
    Title
    Evaluate the long-term relapse rate in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
    Description
    Collect of relapses
    Time Frame
    1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient included in the RITUXIMAB 3 study Major patient who has read and understood the newsletter and signed the consent form Exclusion Criteria: Person deprived of liberty by an administrative or judicial decision Person placed under the safeguard of justice Person under tutorship or curators Pregnant or lactating woman
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pascal JOLY
    Phone
    0033232886841
    Email
    pascal.joly@chu-rouen.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial

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