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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• Children \< 18 years old and ≥ 6 years old at baseline

• Children weight ≥ 20 kg

• All ADS with confirmed anti-MOG-Abs at onset including any acute neurologic symptom with a duration of more than 24H of inflammatory causes (including optic neuritis, transverse myelitis, rhombencephalitis, ADEM, NMOSD) Without any previous treatment other than steroids

• Informed consent signed by both parents and the child

• Expanded Disability Status Scale (EDSS) \< 5.5

• Affiliated to French social security regime

Locations
Other Locations
France
CHU Besançon
NOT_YET_RECRUITING
Besançon
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Brest
NOT_YET_RECRUITING
Brest
HCL de Bron
NOT_YET_RECRUITING
Bron
Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHRU Lille
NOT_YET_RECRUITING
Lille
CHU Monptellier
NOT_YET_RECRUITING
Montpellier
CHU Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU Toulouse Purpan
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Kumaran DEIVA, phD
kumaran.deiva@aphp.fr
0145213112
Backup
Domitille MOLINARI
domitille.molinari@aphp.fr
0145217138
Time Frame
Start Date: 2025-04
Estimated Completion Date: 2030-04
Participants
Target number of participants: 86
Treatments
Experimental: Immediate Azathioprine (1st attack)
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.
Experimental: Immediate Rituximab (1st attack)
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.
Active_comparator: Standard Care: delayed treatment (2nd attack)
Patients will be treated according to standard of care after their 1st attack. In case of relapse:~* before 3 months, IV methylprednisolone (30 mg/kg/j not exceeding 1g/day) will be administered for 3 days. There won't be any change of the initial treatment which will be pursued.~* after 3 months, IV methylprednisolone (30 mg/kg/j not exceeding 1g/day) will be administered for 3 days with an oral relay of prednisolone (1mg/kg/day not exceeding 60 mg/day) during 3 months with then a slowly tapered dose (reduction of 25% every week for 4 weeks). Azathioprine or Rituximab might be proposed as per local clinician experience
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov