Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Immediate Azathioprine (1st attack): Patients randomized in Immediate Azathioprine group will benefit from immediate treatment with azathioprine. Treatment will be started at 2mg/kg or at 1mg/kg if the patient has a partial activity which would be increased slowly according the 6-TGN activity and clinical and biological tolerance at Week 2 for patient with partial activity or M1 for patient without TPMT activity deficit. Only for patient with partial deficit and whose 6-TGN activity is low, azathioprine would be increased at 3mg/kg/d at Week 6 and without exceeding a total daily dose of 150 mg.
Immediate Rituximab (1st attack): Patients randomized in Immediate Rituximab group will benefit from immediate treatment with rituximab. Rituximab 375mg/m2 IV will be given at D1 and D15 and repeat every 6 months for 2 years. Once the inclusion criteria are validated, the first injection will be performed according to the injection protocol (Annex 4). Fifteen day later, the second injection will be performed. The next visit during a consultation with PI or his collaborators will be scheduled 1 week ± 2 days later, and patients will be advised to contact the PI if any neurologic symptoms or symptoms of adverse event occurs in the meantime.
Standard of care: Patients in this group will be treated according to standard care
Study summary
Among all non viral encephalitis, myelin oligodendrocytes glycoprotein antibody associated diseases (MOGAD) are the second most frequent diagnosis in children. Risk of relapses varies according to studied cohorts and cognitive and academic difficulties are more and more detected in children without knowing if these sequelae are related to the first attack or relapses. The hypothesis is that earlier treatment would induce reduction of sequelae after the first attack and the number of relapses which would be also associated with a subsequent reduction of disability occurrence on the long term.
Eligibility
Primary outcome measure(s)
- annualized relapse rate (ARR) at 24 months — at 24 months
To compare the efficacy of immediate (at first attack) azathioprine (AZA) or rituximab (RTX) treatment in children with MOG antibodies positive diseases with delayed treatment (at second attack), on the annualized relapse rate at 24 months.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Besançon | Besançon | France | Not Yet Recruiting |
| CHU Bordeaux | Bordeaux | France | Not Yet Recruiting |
| CHU Brest | Brest | France | Not Yet Recruiting |
| HCL de Bron | Bron | France | Not Yet Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Recruiting |
| CHRU Lille | Lille | France | Not Yet Recruiting |
| CHU Monptellier | Montpellier | France | Not Yet Recruiting |
| CHU Strasbourg | Strasbourg | France | Not Yet Recruiting |
| CHU Toulouse Purpan | Toulouse | France | Not Yet Recruiting |
More Assistance Publique - Hôpitaux de Paris 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 NCT05545384 on ClinicalTrials.gov ↗ ← All trials in France