NCT05545384|RecruitingPhase 3DMC
Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial
IDAR
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
86
1 country
9
Study Start
June 23, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2022
Actual (reported)September 19, 2022
Actual (reported)June 23, 2025
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
annualized relapse rate (ARR) at 24 months
To compare the efficacy of immediate (at first attack) azathioprine (AZA) or rituximab (RTX) treatment in children with MOG antibodies positive diseases with delayed treatment (at second attack), on the annualized relapse rate at 24 months.
at 24 months
Annualized relapse rate at 12 months
at 12 months
Time to first relapse (2nd attack) will be defined as time from randomization to the date of first relapse, with right-censoring in case of loss of follow-up
through study completion, an average of 2.5 years
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.
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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
AZATHIOPRINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
METHYLPREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
AZATHIOPRINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
PREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
AZATHIOPRINE
Named ingredient: Azathioprine
View registry recordMETHYLPREDNISOLONE
Named ingredient: Methylprednisolone
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordAZATHIOPRINE
Named ingredient: Azathioprine
View registry recordPREDNISOLONE
Named ingredient: Prednisolone
View registry recordRITUXIMAB
Named ingredient: Rituximab
View registry recordCHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU Brest
First Submitted
September 6, 2022
First Posted
September 19, 2022
Study Start
June 23, 2025
Actual (reported)Percentage of patients free of relapses over 24 months
through study completion, an average of 2.5 years
Motor disability outcome will be assessed with Expanded Disability Status Scale (EDSS) score
through study completion, an average of 2.5 years
Visual Acuity, Optical Coherence Tomography
at 3, 6, 12 and 24 months
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
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.
Patients in this group will be treated according to standard care
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
TABLET
Formulated product
RITUXIMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordContact the study team to confirm eligibility.
Brest, France
HCL de Bron
Bron, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHRU Lille
Lille, France
CHU Monptellier
Montpellier, France
CHU Strasbourg
Strasbourg, France
CHU Toulouse Purpan
Toulouse, France
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 31, 2026
Record last verified: 2026-08
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