Status:
RECRUITING
Azathioprine in MOGAD
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Central Nervous System Inflammation
MOG-IgG Associated Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2029
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05349006
Start Date
December 12 2023
End Date
December 12 2029
Last Update
February 4 2025
Active Locations (17)
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1
Department of Neurology, CHU de Bordeaux - GH Pellegrin
Bordeaux, France
2
Department of Neurology, CHU of Lille, Hospital Roger Salengro
Lille, France
3
Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer
Lyon, France
4
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