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
About this trial
This is an interventional treatment trial for Autoimmune Diseases
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
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
NCT ID
NCT03790293
First Posted
October 8, 2018
Last Updated
December 27, 2018
Sponsor
University Hospital, Rouen
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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