Relapsing-Remitting Multiple SclerosisSONATA-MSNCT07827586
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 1,800 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2026to 31 May 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana, 1000
About this study
Official 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)
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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Ocrelizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Also called Ocrevus
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ocrelizumab | |
| 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. Receives: Drug: Ocrelizumab | |
| 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. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
Measured: At Month 12
Secondary outcomes (7)
Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12
Measured: At Month 12
Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12
Measured: Baseline, Months 6 and 12
Annualized Relapse Rate (ARR) From Baseline to Month 12
Measured: Baseline to Month 12
Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation
Measured: Baseline to Month 12
Proportion of Participants Persistent on Treatment From Baseline Through Month 12
Measured: Baseline to Month 12
Incidence, Severity and Outcomes of Adverse Events (AEs)
Measured: Up to 2.6 years
Duration of AEs
Measured: Up to 2.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827586
- Sponsor's protocol ID
- MN46738
- Acronym
- SONATA-MS
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No