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Recruiting
NCT07827586
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Conditions: Relapsing-Remitting Multiple Sclerosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1800
Sponsor: Hoffmann-La Roche
Location: University Medical Centre Ljubljana
Summary
The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).
* Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.
* The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.
* Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.
Exclusion Criteria:
* Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.
* Prior treatment with rituximab.
* Contraindications to ocrelizumab as per the local prescribing information.
* Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.
* Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.
* For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available.
Source: ClinicalTrials.gov (NCT07827586). StuddyBuddy aggregates publicly available trial information.