Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in MS
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 Haydarpa?a Numune Training and Research Hospital, Neurology Department. The ...
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 Haydarpa?a 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.
Tracking Information
- NCT #
- NCT04874597
- Collaborators
- Health Sciences University Istanbul Haydarpa?a Numune Training and Research Hospital
- Investigators
- Not Provided