Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial
LTFURITUX3
1 other identifier
interventional
80
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2018
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2018
CompletedStudy Start
First participant enrolled
November 17, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2019
CompletedFebruary 6, 2026
February 1, 2026
5 months
October 8, 2018
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study
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
1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study
Study Arms (2)
Rituximab
EXPERIMENTALRituximab in combination with reduced corticosteroids is administrated
Standard corticosteroid
ACTIVE COMPARATORStandard corticosteroid is administrated
Interventions
Patient was enrolled into the RITUXIMAB 3 study in the arm Rituximab in association with low corticosteroids'therapy
Patient was enrolled into the RITUXIMAB 3 study in the arm Patient was enrolled into the RITUXIMAB 3 study in the arm standard corticosteroid
Eligibility Criteria
You may qualify if:
- Patient included in the RITUXIMAB 3 study
- Major patient who has read and understood the newsletter and signed the consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Chu Angers
Angers, 49100, France
Ap-Hp Avicenne
Bobigny, 93000, France
Chu Bordeaux
Bordeaux, 33076, France
Chu Brest
Brest, 29200, France
Chu Clermont-Ferrand
Clermont-Ferrand, 63100, France
Ap-Hp Henri Mondor
Créteil, 94010, France
Chu Dijon
Dijon, 21000, France
Ch Le Mans
Le Mans, 72037, France
Chru Lille
Lille, 59000, France
Chu Limoges
Limoges, 87000, France
Hcl Edouard Herriot
Lyon, 69003, France
Hcl Ch Lyon Sud
Lyon, 69310, France
Ap-Hm La Timone
Marseille, 13385, France
Chu Montpellier
Montpellier, 34090, France
Chu Nantes
Nantes, 44000, France
Ah-Hp Cochin
Paris, 75006, France
Ap-Hp Saint-Louis
Paris, 75010, France
Ap-Hp Cochin
Paris, 75014, France
Ap-Hp Bichat
Paris, 75018, France
Chu Reims
Reims, 51092, France
Chu Rennes
Rennes, 35000, France
Chu Rouen
Rouen, 76031, France
Chu Saint-Etienne
Saint-Etienne, 42270, France
Chu Toulouse
Toulouse, 31059, France
Chu Tours
Tours, 37000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2018
First Posted
December 31, 2018
Study Start
November 17, 2018
Primary Completion
April 19, 2019
Study Completion
April 19, 2019
Last Updated
February 6, 2026
Record last verified: 2026-02