Azathioprine in MOGAD
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years. — During a randomized control period of a maximum of three years
A definite relapse will be defined as such: * When a patient is diagnosed as experiencing a relapse by the local investigator, the anonymized file will be reviewed within 4 days by a second investigator neurologist, not aware of the randomization group nor of the center treating the patient. * If this second neurologist also considers the patient as experiencing a relapse, the patient will be considered as relapsing for the main analysis. * If the second neurologist disagrees, the opinion of a third neurologist will be asked and the majority opinion will be retained. As to ensure a maximum of homogeneity, we also propose a protocol-defined criteria for a MOGAD relapse, validated by the steering committee and available to every investigator (see Annex 2).
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Neurology, CHU de Bordeaux - GH Pellegrin | Bordeaux | France | Recruiting |
| Department of Neurology, CHU of Lille, Hospital Roger Salengro | Lille | France | Recruiting |
| Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer | Lyon | France | Recruiting |
| 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 | Recruiting |
| Department of Neurology University hospital Timone | Marseille | France | Recruiting |
| Department of Neurology Montpellier Universitary Hospital | Montpellier | France | Recruiting |
| CHRU de Nancy Hôpital Central | Nancy | France | Recruiting |
| Department of Neurology, Hôpital Pasteur 2 | Nice | France | Not Yet Recruiting |
| Department of Neurology, Hôpital Caremeau | Nîmes | France | Recruiting |
| National Hospital of Vision (15-20) | Paris | France | Recruiting |
| Department of Neurology APHP, Pitié Salpêtrière Hospital | Paris | France | Recruiting |
| Department of Neurology. Hôpital A. Fondation Rothschild | Paris | France | Recruiting |
| Department of Neurology, CHU de Rennes | Rennes | France | Recruiting |
| Department of Neurology, CHU de Rouen | Rouen | France | Recruiting |
| Department of Neurology, Hôpital g. Et r. Laennec | Saint-Herblain | France | Recruiting |
| Department of Neurology, Hôpital Hautepierre | Strasbourg | France | Recruiting |
| Department of Neurology, Toulouse Universitary Hospital | Toulouse | France | Recruiting |
More Hospices Civils de Lyon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05349006 on ClinicalTrials.gov ↗ ← All trials in France