Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2030

Conditions
Acute Demyelinating Syndrome
Interventions
DRUG

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."

DRUG

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."

DRUG

Standard of care

Patients in this group will be treated according to standard care

Trial Locations (9)

94270

RECRUITING

Hôpital Bicêtre, Le Kremlin-Bicêtre

Unknown

NOT_YET_RECRUITING

CHU Besançon, Besançon

NOT_YET_RECRUITING

CHU Bordeaux, Bordeaux

NOT_YET_RECRUITING

CHU Brest, Brest

NOT_YET_RECRUITING

HCL de Bron, Bron

NOT_YET_RECRUITING

CHRU Lille, Lille

NOT_YET_RECRUITING

CHU Monptellier, Montpellier

NOT_YET_RECRUITING

CHU Strasbourg, Strasbourg

NOT_YET_RECRUITING

CHU Toulouse Purpan, Toulouse

All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER