Comparing immediate and delayed treatments for children with anti-MOG antibody-related acute demyelinating syndromes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of immediate versus delayed treatment with Azathioprine or Rituximab in children diagnosed with acute demyelinating syndromes associated with anti-MOG antibodies. The study aims to determine whether early intervention can reduce long-term neurological sequelae and the frequency of relapses compared to standard care. Children aged 6 to 18 years with confirmed anti-MOG antibodies and specific acute neurological symptoms will be enrolled. The trial will assess the efficacy of these treatments in improving patient outcomes over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Current infection with SARS-COV2 (positive PCR)
* Any prior allergy to azathioprine or rituximab with hypersensitivity to active substances, murine proteins or to any of the excipients.
* Any prior history of uncontrolled cancer during the last 2 years
* Uncontrolled infections (Hepatitis B, C and HIV)
* Any prior history of cardiac dysfunction and/or hypertension
* Any progressive or non-relapsing form demyelinating diseases
* Any previous treatment with natalizumab, daclizumab, fingolimod, methotrexate, cyclosporine, mycophenolate mofetil, rituximab in the last 6 months, or determined by the treating physician to have residual immune suppression from these or other immunosuppressive treatments
* CD4+, CD8+, or CD19+ absolute cell count, wbc, neutrophiles in blood at screening below lower limits of normal (LLN)
* Creatinine\>30µmol/L
* Platelets \<70 000mm3
* Haemoglobin \< 8g/dL
* Acute renal insufficiency (clearance \< 30 ml/min)
* Prior documented history of hemostase perturbation (TP and/or TCA more than twice of the witnesse's TP and/or TCA)
* Prior documented history of increased liver enzyme level (ASAT and/or ALAT) \> 2N.
* TP \<70%
* Total bilirubin \> 2N
* Any patient with allopurinol treatment and immunosupressive treatment with concomitant use of xanthine oxidase inhibitors (e.g. allopurinol, oxipurinol/thiopurinol, febuxostat)
* Patients with two inactive TPMT or NUDT15 alleles (homozygous deficient or double heterozygote)
* Pregnancy or lactating woman or wish for future pregnancy
* Refusal to have a highly effective contraception during traitment and for one year (12 months) after the end of the experimental treatment
* participation to another interventional study within 5 half-lives prior to baseline.
* Active, severe infections (including tuberculosis, HBV and HCV, HIV, herpes, VZV, EBV and CMV)
* Psychosis not controlled by treatment
* Patients with Lesch Nyhan syndrome
* Pheochromocytoma
* Scleroderma
* Untreated peptic ulcer
* Myasthenia gravis
* Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation

Where it's running

• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• 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
• CHRU Lille
  Lille, France Not yet recruiting

Study contacts

• Study coordinator: Kumaran DEIVA, phD
• Email: kumaran.deiva@aphp.fr
• Phone: 0145213112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.