Relapsing-Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
Peak concentration (Cmax) and area under the concentration-time curve over a dosing interval (AUCtau) after the first SC injection
Detailed description
Rate and nature of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Change from baseline in selected vital signs and clinical significant abnormalities in ECG, Change from baseline in selected clinical laboratory test results, Rate of study treatment discontinuation due to adverse events, Levels of CD19+ B cell count in blood, Incidence of treatment-emergent anti-drug antibodies (ADAs) during the study relative to the presence of ADAs at baseline, The relationship between ADA status and pharmacokinetics and safety
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration (Cmax) and area under the concentration-time curve over a dosing interval (AUCtau) after the first SC injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate and nature of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Change from baseline in selected vital signs and clinical significant abnormalities in ECG, Change from baseline in selected clinical laboratory test results, Rate of study treatment discontinuation due to adverse events, Levels of CD19+ B cell count in blood, Incidence of treatment-emergent anti-drug antibodies (ADAs) during the study relative to the presence of ADAs at baseline, The relationship between ADA status and pharmacokinetics and safety | — |
Outcome results
None listed