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NCT07827586Recruiting

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)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1800 (estimated)
First submitted
15 Sept 2026
Start date
23 Sept 2026
Primary completion date
31 Jan 2029
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07827586

What you commit to

  • Study type: Observational
  • Planned participants: 1800
  • From 23 Sept 2026 to the primary completion date, 31 Jan 2029
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with rituximab.

Other illness

  • Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.
  • 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.

Other

  • Contraindications to ocrelizumab as per the local prescribing information.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Coordinator of this site? Confirm its status
PardubiceCzechiaRecruiting
University Medical Centre
Coordinator of this site? Confirm its status
LjubljanaSloveniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.