Relapsing-Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
1.Serum concentration of ocrelizumab at specified timepoints, 2.Levels of CD19+ B-cell count in blood
Detailed description
1.Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), 2.Change from baseline in vital signs, 3.Change from baseline in clinical laboratory test results, 4.Level of circulating B cells, T cells, natural killer cells, and other leukocytes, 5.Developmental milestones (e.g., growth, bone age, age at menarche, Tanner staging), 6.Non-MS central nervous system (CNS) pathology as measured by brain MRI scans, 7.Levels of blood immunoglobulins, 8.Antibody titers against standard vaccines, 9.Presence of ADAs during the study relative to the presence of ADAs at baseline
Interventions
DRUGOcrevus 300 mg concentrate for solution for infusion
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Serum concentration of ocrelizumab at specified timepoints, 2.Levels of CD19+ B-cell count in blood | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), 2.Change from baseline in vital signs, 3.Change from baseline in clinical laboratory test results, 4.Level of circulating B cells, T cells, natural killer cells, and other leukocytes, 5.Developmental milestones (e.g., growth, bone age, age at menarche, Tanner staging), 6.Non-MS central nervous system (CNS) pathology as measured by brain MRI scans, 7.Levels of blood immunoglobulins, 8.Antibody titers against standard vaccines, 9.Presence of ADAs during the study relative to the presence of ADAs at baseline | — |
Countries
Italy, Poland
Outcome results
None listed