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NCT Number: NCT07827586

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ocrelizumab

Drug

Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.

Other names: Ocrevus

Primary outcomes

  1. Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12

    Time frame: At Month 12

Secondary outcomes

  1. Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12

    Time frame: At Month 12

  2. Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12

    Time frame: Baseline, Months 6 and 12

  3. Annualized Relapse Rate (ARR) From Baseline to Month 12

    Time frame: Baseline to Month 12

  4. Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation

    Time frame: Baseline to Month 12

  5. Proportion of Participants Persistent on Treatment From Baseline Through Month 12

    Time frame: Baseline to Month 12

  6. Incidence, Severity and Outcomes of Adverse Events (AEs)

    Time frame: Up to 2.6 years

  7. Duration of AEs

    Time frame: Up to 2.6 years

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: SONATA-MS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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