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IDAR.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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516243-81-00
Acronym
APHP211057
Enrollment
86
Registered
2024-10-24
Start date
2025-06-23
Completion date
Unknown
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelin oligodendrocytes glycoprotein antibody associated diseases (MOGAD)

Brief summary

The primary endpoint will be the annualized relapse rate (ARR) at 24 months.

Detailed description

Comparison between immediate-AZA and immediate - Annualized relapse rate at 12 and 24 months, Comparison between immediate-AZA and delayed-treatment - Annualized relapse rate at 12 and 24 months, Comparison between immediate-RTX and delayed-treatment - Annualized relapse rate at 12 and 24 months, Other clinical outcome for comparing immediate- and delayedtreatment, Radiological outcome, Immunological studies

Interventions

DRUGAZATHIOPRINE
DRUGMETHYLPREDNISOLONE
DRUGPREDNISONE
DRUGPREDNISOLONE
DRUGRITUXIMAB

Sponsors

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be the annualized relapse rate (ARR) at 24 months.—

Secondary

MeasureTime frame
Comparison between immediate-AZA and immediate - Annualized relapse rate at 12 and 24 months, Comparison between immediate-AZA and delayed-treatment - Annualized relapse rate at 12 and 24 months, Comparison between immediate-RTX and delayed-treatment - Annualized relapse rate at 12 and 24 months, Other clinical outcome for comparing immediate- and delayedtreatment, Radiological outcome, Immunological studies—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026