Actively Recruiting
Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-07
86
Participants Needed
9
Research Sites
260 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to under 18 years at baseline
- Children weighing 20 kg or more
- Diagnosis of Acute Demyelinating Syndrome (ADS) with confirmed anti-MOG antibodies at onset, including symptoms lasting more than 24 hours such as optic neuritis, transverse myelitis, rhombencephalitis, ADEM, or NMOSD
- No previous treatment other than steroids
- Signed informed consent by both parents and the child
- Expanded Disability Status Scale (EDSS) score below 5.5
- Affiliation to the French social security system
You will not qualify if you...
- Current infection with SARS-COV2 (positive PCR test)
- Allergy or hypersensitivity to azathioprine, rituximab, murine proteins, or any drug components
- History of uncontrolled cancer within the past 2 years
- Uncontrolled infections including hepatitis B, hepatitis C, or HIV
- History of cardiac dysfunction or hypertension
- Progressive or non-relapsing demyelinating diseases
- Treatment with natalizumab, daclizumab, fingolimod, methotrexate, cyclosporine, mycophenolate mofetil, or rituximab in the last 6 months or residual immune suppression
- Low blood cell counts below normal limits at screening
- Elevated creatinine above 30 µmol/L
- Platelets less than 70,000/mm3
- Hemoglobin less than 8 g/dL
- Acute kidney failure (clearance below 30 ml/min)
- History of blood clotting disorders
- Elevated liver enzymes more than twice normal
- Prothrombin time less than 70%
- Total bilirubin above twice normal
- Use of allopurinol or other xanthine oxidase inhibitors with immunosuppressive therapy
- Genetic deficiencies affecting drug metabolism (TPMT or NUDT15 alleles)
- Pregnancy, breastfeeding, or desire for future pregnancy
- Refusal to use effective contraception during treatment and 12 months after
- Participation in another interventional study within 5 drug half-lives prior to baseline
- Active severe infections including tuberculosis, herpes, varicella-zoster, Epstein-Barr, or cytomegalovirus
- Untreated psychosis
- Diagnosis of Lesch Nyhan syndrome, pheochromocytoma, scleroderma, untreated peptic ulcer, or myasthenia gravis
- Any other medical condition that could interfere with trial participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
CHU Besançon
Besançon, France
Not Yet Recruiting
2
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
3
CHU Brest
Brest, France
Not Yet Recruiting
4
HCL de Bron
Bron, France
Not Yet Recruiting
5
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
6
CHRU Lille
Lille, France
Not Yet Recruiting
7
CHU Monptellier
Montpellier, France
Not Yet Recruiting
8
CHU Strasbourg
Strasbourg, France
Not Yet Recruiting
9
CHU Toulouse Purpan
Toulouse, France
Not Yet Recruiting
Research Team
K
Kumaran DEIVA, phD
CONTACT
D
Domitille MOLINARI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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