Informations générales (source: ClinicalTrials.gov)
A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease
Interventional
Phase 3
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2023
décembre 2029
29 août 2025
MOG-IgG associated disease (MOGAD) is a rare inflammatory disease of the central nervous
system recently described. Initially reported as monophasic, data from incident cohorts
suggests that around 50% of adult patients with MOG-Ab may relapse within the first two
years of the disease, with most of relapses occurring early after disease onset.
No randomized controlled trial has ever been performed and therapeutic guidelines for
this disease remain unclear especially after a single event. In short-sized and mainly
retrospective study, azathioprine, an immunosuppressant drug, have showed promising
results on preventing the risk of relapse in MOGAD patients.
The hypothesis is that the initiation of a treatment after a first attack of MOGAD should
prevent further relapse and disability accrual. The investigators propose herein the
first randomized controlled trial in MOGAD, to evaluate the efficacy of azathioprine to
prevent relapses, after a first attack, in a placebo double-blinded design.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Romain DESCHAMPS | 21/06/2024 13:35:06 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Nancy Hôpital Central - 54035 - Nancy - France | Guillaume MATHEY, md | Contact (sur clinicalTrials) | |||
| Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer - Lyon - France | Caroline FROMENT, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology APHP, Pitié Salpêtrière Hospital - Paris - France | Elisabeth MAILLART, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology Montpellier Universitary Hospital - Montpellier - France | Xavier AYRIGNAC, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology University hospital Timone - Marseille - France | Bertrand AUDOIN, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology, CHU de Bordeaux - GH Pellegrin - Bordeaux - France | Aurélie RUET, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology, CHU de Rennes - Rennes - France | Laure MICHEL, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology, CHU de Rouen - Rouen - France | Bertrand BOURRE, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology, CHU of Lille, Hospital Roger Salengro - Lille - France | Helene ZEPHIR, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology, Hôpital Caremeau - Nîmes - France | Eric THOUVENOT, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology, Hôpital g. Et r. Laennec - Saint-Herblain - France | David LAPLAUD, Pr | Contact (sur clinicalTrials) | |||
| Department of Neurology, Hôpital Hautepierre - Strasbourg - France | Nicolas COLLONGUES, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology, Hôpital Pasteur 2 - Nice - France | Mikael COHEN, Dr | Contact (sur clinicalTrials) | |||
| Department of Neurology, Toulouse Universitary Hospital - Toulouse - France | Jonathan CIRON, Dr | Contact (sur clinicalTrials) | |||
| National Hospital of Vision (15-20) - 75012 - Paris - France | Jennifer ABOAB, MD | Contact (sur clinicalTrials) | |||
| Service de Neurologie sclérose en plaques, pathologies de la myéline et neuro-inflammation - Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon - Lyon - France | Romain MARIGNIER, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- First attack of documented acute demyelinating syndrome of the central nervous
system, within the past 3 months, whatever the severity or the clinical phenotype
- Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral centre)
- Ability of the subject to understand the purpose and risks of the study and provide
signed and dated written informed consent.
- Patients should be beneficiary of health care coverage under the social security
system
- Female patients of childbearing potential should have effective contraception
throughout the course of treatment and for at least three months after stopping
treatment.
- Age ≥ 18 years
- First attack of documented acute demyelinating syndrome of the central nervous
system, within the past 3 months, whatever the severity or the clinical phenotype
- Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral centre)
- Ability of the subject to understand the purpose and risks of the study and provide
signed and dated written informed consent.
- Patients should be beneficiary of health care coverage under the social security
system
- Female patients of childbearing potential should have effective contraception
throughout the course of treatment and for at least three months after stopping
treatment.
- Hypersensitivity to azathioprine or steroids
- Active infections or cancer (including tuberculosis, hepatitis, herpes and VZV)
- Psychosis not controlled by treatment
- Seriously impaired bone marrow functions: Lymphocyte count < 1000/ml and or
Polynuclear neutrophil count < 1500/ml
- Seriously impaired hepatic functions: ALT and/or AST > 3N
- Seriously impaired renal functions: GFR < 29 ml/min/1.73m²
- Any live vaccine in the past 3 months or planned during the RCT and RCT+6months
- Thiopurine methyltransferase (TPMT) phenotype deficient or intermediate, with
enzymatic activity < 16 nmol/h/ml
- Unable to complete an MRI (e.g. due to pacemaker, severe claustrophobia,
hypersensitivity to contrast media, or who lack adequate peripheral venous access)
- Necessary use of a xanthine oxidase inhibitor (Allopurinol, Oxipurinol, Thiopurinol,
Febuxotat,...)
- Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine
and indometacine
- Necessary use of an aminosalicylate derivates
- Necessary use of any another immunosuppressive therapy, different than azathioprine,
or steroids
- Necessary use of cytotoxic therapy
- Necessary use of any other medical illness or disability that, in the opinion of the
investigator, would compromise effective trial participation
- Current enrollment or a plan to enroll in any interventional clinical study in which
an investigational treatment or approved therapy is use within 5 half-lives prior to
baseline. Participation in a non- interventional study can be allowed as long as
this participation does not interfere with this protocol or is not likely to affect
the subject's ability to comply with the protocol.
- For subjects coming back from strongyloidiasis endemic regions, a parasitology
screening examination will be performed on faeces, and that appropriate treatment
will be performed prior to administration of corticosteroids
- Patients with Lesch Nyhan syndrome
- Asian patients (probable mutation of the gene NUDT1)
- Female subjects who have a positive a positive urinary or blood pregnancy test
result, are pregnant or are currently breast feeding
- Inability to comply with study requirements
- Person under legal protection or deprived of liberty