A clinical trial to compare the safety and effectiveness of ocrelizumab with fingolimod in children and young people with relapsing-remitting multiple sclerosis (RRMS)

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

  • 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:

Aktiv, keine Rekrutierung

Diese Studie läuft in
Städte
  • datteln
  • Dresden
  • Göttingen
  • Münster
Studien-ID:

NCT05123703 2020-004128-41 2023-506516-40-00 WN42086

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      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, 2020-004128-41,2023-506516-40-00 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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