Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 14, 2022
Trial Information
Current as of July 13, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the effects of starting treatment right away compared to waiting to treat children with a condition called Acute Demyelinating Syndrome (ADS) that is associated with anti-MOG antibodies. The researchers want to see if treating these children earlier with medications called azathioprine or rituximab can help reduce long-term problems and the chances of having more relapses in the future. This study is important because children with this condition can face challenges in learning and development, and the goal is to find out if immediate treatment can improve their overall health and quality of life.
To participate in the trial, children between the ages of 6 and 17 who weigh at least 20 kg and have specific confirmed symptoms related to ADS may be eligible. They must not have received any treatment other than steroids before joining the study. Parents or guardians will need to provide consent for their child to participate. During the study, participants will receive one of the treatments and will be monitored closely to see how they respond. It’s also important to note that some children with certain medical conditions or those currently sick with infections may not be able to join the trial.
Gender
ALL
Eligibility criteria
- 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lille, , France
Bordeaux, , France
Strasbourg, , France
Toulouse, , France
Brest, , France
Besançon, , France
Le Kremlin Bicetre, , France
Bron, , France
Montpellier, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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