SONATA-MS
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
At Month 12
Quality of life (reported by participants)
Other measures (7)
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
Blood or spinal fluid markersAnnualized Relapse Rate (ARR) From Baseline to Month 12
Baseline to Month 12
RelapsesProportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation
Baseline to Month 12
RelapsesProportion 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
SafetyDuration of AEs
Up to 2.6 years
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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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History
Started
Sept 2026
Main results due
Jan 2029
Finished
May 2029
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