Actively Recruiting
Azathioprine in MOGAD
Led by Hospices Civils de Lyon · Updated on 2025-02-04
126
Participants Needed
17
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Azathioprine in MOGAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- First attack of documented acute demyelinating syndrome of the central nervous system within the past 3 months, regardless of severity or clinical type
- Positive test for MOG antibodies confirmed by a centralized laboratory
- Ability to understand study purpose and risks and provide written informed consent
- Beneficiary of health care coverage under the social security system
- Female patients of childbearing potential must use effective contraception during treatment and for at least three months after stopping treatment
You will not qualify if you...
- Allergy or hypersensitivity to azathioprine or steroids
- Active infections or cancer including tuberculosis, hepatitis, herpes, or varicella zoster virus
- Psychosis not controlled by treatment
- Severely impaired bone marrow function (lymphocyte count < 1000/ml or neutrophil count < 1500/ml)
- Severely impaired liver function (ALT and/or AST > 3 times normal)
- Severely impaired kidney function (glomerular filtration rate < 29 ml/min/1.73 m²)
- Receipt of any live vaccine within the past 3 months or planned during the study and 6 months after
- Deficient or intermediate thiopurine methyltransferase (TPMT) enzyme activity (<16 nmol/h/ml)
- Inability to complete MRI due to pacemaker, severe claustrophobia, contrast media allergy, or lack of venous access
- Required use of certain medications including xanthine oxidase inhibitors, angiotensin-converting enzyme inhibitors, cotrimoxazole, cimetidine, indometacine, aminosalicylate derivatives, other immunosuppressive or cytotoxic therapies
- Any medical illness or disability that may affect trial participation as judged by investigator
- Current or planned enrollment in another interventional clinical trial involving investigational or approved therapies within 5 half-lives prior to baseline
- Patients returning from strongyloidiasis endemic areas without appropriate parasitology screening and treatment
- Diagnosis of Lesch Nyhan syndrome
- Asian patients due to probable NUDT1 gene mutation
- Positive pregnancy test, pregnancy, or breastfeeding
- Inability to comply with study requirements
- Persons under legal protection or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Department of Neurology, CHU de Bordeaux - GH Pellegrin
Bordeaux, France
Actively Recruiting
2
Department of Neurology, CHU of Lille, Hospital Roger Salengro
Lille, France
Actively Recruiting
3
Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer
Lyon, France
Actively Recruiting
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
Actively Recruiting
5
Department of Neurology University hospital Timone
Marseille, France
Actively Recruiting
6
Department of Neurology Montpellier Universitary Hospital
Montpellier, France
Actively Recruiting
7
CHRU de Nancy Hôpital Central
Nancy, France, 54035
Actively Recruiting
8
Department of Neurology, Hôpital Pasteur 2
Nice, France
Not Yet Recruiting
9
Department of Neurology, Hôpital Caremeau
Nîmes, France
Actively Recruiting
10
National Hospital of Vision (15-20)
Paris, France, 75012
Actively Recruiting
11
Department of Neurology APHP, Pitié Salpêtrière Hospital
Paris, France
Actively Recruiting
12
Department of Neurology. Hôpital A. Fondation Rothschild
Paris, France
Actively Recruiting
13
Department of Neurology, CHU de Rennes
Rennes, France
Actively Recruiting
14
Department of Neurology, CHU de Rouen
Rouen, France
Actively Recruiting
15
Department of Neurology, Hôpital g. Et r. Laennec
Saint-Herblain, France
Actively Recruiting
16
Department of Neurology, Hôpital Hautepierre
Strasbourg, France
Actively Recruiting
17
Department of Neurology, Toulouse Universitary Hospital
Toulouse, France
Actively Recruiting
Research Team
R
Romain MARIGNIER, MD PhD
CONTACT
L
Lakhdar BENYAHYA, project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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