ClinicalTrials.gg
RecruitingNCT07827586SONATA-MSUpdated Oct 30, 2026

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

An observational study in Relapsing-Remitting Multiple Sclerosis, sponsored by Hoffmann-La Roche. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Hoffmann-La Roche · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 30, 2026Now RecruitingFirst sites in Slovenia and Czechia+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,800
Ages
18 Years and older
Sex
All
01

Study 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. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.

02

Conditions studied

  • Relapsing-Remitting Multiple Sclerosis
03

In context

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
  • to ocrelizumab as per the local prescribing information.
  • Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,800 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

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

    Also known as: Ocrevus

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
    Pardubice, Pardubice Region 532 03, Czechia
    Recruiting
  • University Medical Centre
    Ljubljana, 1000, Slovenia
    Recruiting
08

References and documents

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
2 sites added — first sites in Slovenia and Czechia
Show 2 added (1 Slovenia, 1 Czechia)
  • University Medical Centre · Ljubljana, Slovenia
  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice · Pardubice, Czechia
across 2 updates, Sep 28, 2026 – Oct 30, 2026
Start date
Sep 30, 2026→Sep 23, 2026 (actual)
Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    1 site added — first site in Czechia
    Show site
    • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice · Pardubice, Czechia
    Start date Sep 30, 2026→Sep 23, 2026 (now actual)
    + 1 other change: verification date
  2. Sep 28, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Slovenia
    Show site
    • University Medical Centre · Ljubljana, Slovenia

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07827586
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 23, 2026
Primary completion
Jan 31, 2029 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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