Multiple Sclerosis (MS)
Conditions
Brief summary
The primary PK parameters of ocrelizumab: area under the serum concentration−time curve (AUC) and maximum serum concentration observed (Cmax)
Detailed description
Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale, Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary PK parameters of ocrelizumab: area under the serum concentration−time curve (AUC) and maximum serum concentration observed (Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale, Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed