Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants diagnosed with RRMS who are treated with ocrelizumab s.c. for the first time (initial treatment or treatment switch) as part of their multiple sclerosis (MS) therapy during routine clinical practice

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Treatment-naive participants initiating ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.	Drug: Ocrelizumab; Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.; Other Names: Ocrevus
Cohort 2; Participants who were receiving ocrelizumab i.v. and then switched to ocrelizumab s.c., representing a change in route of administration as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.	Drug: Ocrelizumab; Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.; Other Names: Ocrevus
Cohort 3; Treatment experienced participants who were receiving prior DMTs and then switched to ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.	Drug: Ocrelizumab; Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.; Other Names: Ocrevus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12	At Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12	At Month 12
Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12	Baseline, Months 6 and 12
Annualized Relapse Rate (ARR) From Baseline to Month 12	Baseline to Month 12
Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation	Baseline to Month 12
Proportion of Participants Persistent on Treatment From Baseline Through Month 12	Baseline to Month 12
Incidence, Severity and Outcomes of Adverse Events (AEs)	Up to 2.6 years
Duration of AEs	Up to 2.6 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: September 15, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; ocrelizumab
• Other Study ID Numbers: MN46738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No