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 2 sites in 2 countries.
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
- 2 sitesin 2 countries
- Study dates
- 23 Sep 2026to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
2 sites in 2 countries. 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
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, Pardubice Region, 532 03
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 start23 Sep 2026
- 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
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07827586
- Acronym / sponsor ID
- SONATA-MS / MN46738
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: OcrelizumabTreatment-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. |
| Cohort 2 | – | Drug: OcrelizumabParticipants 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. |
| Cohort 3 | – | Drug: OcrelizumabTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabAlso: OcrevusOcrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
Time frame: At Month 12
7 secondary outcomes
Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12
Time frame: At Month 12
Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12
Time frame: Baseline, Months 6 and 12
Annualized Relapse Rate (ARR) From Baseline to Month 12
Time frame: Baseline to Month 12
Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation
Time frame: Baseline to Month 12
Proportion of Participants Persistent on Treatment From Baseline Through Month 12
Time frame: Baseline to Month 12
Incidence, Severity and Outcomes of Adverse Events (AEs)
Time frame: Up to 2.6 years
Duration of AEs
Time frame: Up to 2.6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take 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
Clinical Trials study director
Hoffmann-La Roche
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12 (time frame: At Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.