Clinical Research Directory
Browse clinical research sites, groups, and studies.
Azathioprine in MOGAD
Sponsor: Hospices Civils de Lyon
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% 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.
Official title: A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2023-12-12
Completion Date
2029-12-12
Last Updated
2025-02-04
Healthy Volunteers
No
Interventions
Azathioprine
Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight \> 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period
Placebo
Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight \> 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period
Locations (17)
Department of Neurology, CHU de Bordeaux - GH Pellegrin
Bordeaux, France
Department of Neurology, CHU of Lille, Hospital Roger Salengro
Lille, France
Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer
Lyon, France
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
Department of Neurology University hospital Timone
Marseille, France
Department of Neurology Montpellier Universitary Hospital
Montpellier, France
CHRU de Nancy Hôpital Central
Nancy, France
Department of Neurology, Hôpital Pasteur 2
Nice, France
Department of Neurology, Hôpital Caremeau
Nîmes, France
National Hospital of Vision (15-20)
Paris, France
Department of Neurology APHP, Pitié Salpêtrière Hospital
Paris, France
Department of Neurology. Hôpital A. Fondation Rothschild
Paris, France
Department of Neurology, CHU de Rennes
Rennes, France
Department of Neurology, CHU de Rouen
Rouen, France
Department of Neurology, Hôpital g. Et r. Laennec
Saint-Herblain, France
Department of Neurology, Hôpital Hautepierre
Strasbourg, France
Department of Neurology, Toulouse Universitary Hospital
Toulouse, France