A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID/ NCT04075266
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2023-08-29
Brief 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
INTERVENTION / TREATMENT
Drug: Ocrelizumab
| Category | Value |
|---|---|
| Study Start (Actual) | 2020-01-09 |
| Primary Completion (Estimated) | 2023-12-31 |
| Study Completion | 2029-12-01 |
| Enrollment (Estimated) | 36 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers | WA39085 2016-002667-34 ( EudraCT Number ) |