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Eine Studie zur Beurteilung der Sicherheit und Wirksamkeit von Ocrelizumab im Vergleich zu Fingolimod bei Kindern und Jugendlichen mit schubförmig remittierender Multipler Sklerose
A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis (Operetta 2)
- Autoimmunerkrankung
- Multiple Sklerose (MS)
- schubförmige remittierende MS
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Rekrutierung läuft
Diese Studie läuft in
Städte
- datteln
- Dresden
- Göttingen
- Münster
Studien-ID:
NCT05123703 2020-004128-41 WN42086
Studienzusammenfassung
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05123703,WN42086,2020-004128-41
Studien-ID
Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo
Treatments
Relapsing-Remitting Multiple Sclerosis
Condition
Official Title
A phase III multicenter, randomized, double-blind, double-dummy study to evaluate safety and efficacy of ocrelizumab in comparison with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis
Einschlusskriterien
All
Gender
≥10 Years & ≤ 17 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Body weight ≥ 50 kg
- Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
- EDSS at screening: 0-5.5, inclusive
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
- At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months
Exclusion Criteria
- Known presence or suspicion of other neurologic disorders that may mimic MS
- Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study
- Patient with severe cardiac disease or significant findings on the screening ECG
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