This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab.
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. The study will be conducted on Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department. The decision to treat with ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study and in line with the Summary of Product Characteristics (SmPC) approved by the Turkish Ministry of Health. Data will be recorded at screening visit, baseline visit (month 0), second visit on 6th month, third visit on 12th month and last visit (end of the study \[EOS\]) on 24th month according to local clinic practice. Optional ad hoc visits could be conducted if relapse of MS or infection after vaccination occurs during ocrelizumab treatment. The duration of the study for each patient will be 24 months.
Study Type
OBSERVATIONAL
Enrollment
30
Ocrelizumab treatment will be administered in accordance with the product characteristics approved in Turkey.
Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department
Istanbul, Uskudar, Turkey (Türkiye)
Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry.
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
Time frame: From baseline to month 6 and month 12
Change from baseline in T cell function achieved by eliminating B cells as measured by flow cytometry.
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
Time frame: From baseline to month 6 and month 12
Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.
Time frame: Baseline (month 0), month 6 and month 12
Clinical improvement
Clinical improvement will be confirmed if an increase of less than half a step on the Expanded Disability Status Scale and less than one attack were observed during the first 12 months of ocrelizumab treatment.
Time frame: Baseline (month 0), month 6 and month 12
Changes in T cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Time frame: From baseline (month 0) to month 6 and month 12
Changes in B cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Time frame: From baseline (month 0) to month 6 and month 12
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