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NCT07827586From ClinicalTrials.govRecruiting

Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis

A Prospective Longitudinal Multicenter, Multi-Country, Observational Study Assessing Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)

  • Relapsing-Remitting Multiple Sclerosis

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Hoffmann-La Roche
Enrolment target
1,800
Started
30 September 2026
Main results due
31 January 2029
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • University Medical Centre

    Ljubljana, Slovenia

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07827586. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis | Trialion