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A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
Sponsor: Hoffmann-La Roche
Summary
This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.
Official title: An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
Key Details
Gender
All
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2020-01-09
Completion Date
2029-12-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
Ocrelizumab
Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks. Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg
Locations (12)
University of Colorado Denver Childrens Hospital Rocky Mountain MS Center
Aurora, Colorado, United States
Childrens National Health Center
Washington D.C., District of Columbia, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Washington Universtiy school of Medicine
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego
Warsaw, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland