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

15. september 2026 opdateret af: Hoffmann-La Roche

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: Ocrelizumab
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navne:
  • 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.
Medicin: Ocrelizumab
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navne:
  • 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.
Medicin: Ocrelizumab
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navne:
  • Ocrevus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
Tidsramme: At Month 12
At Month 12

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

31. januar 2029

Studieafslutning (Anslået)

31. maj 2029

Datoer for studieregistrering

Først indsendt

15. september 2026

Først indsendt, der opfyldte QC-kriterier

15. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MN46738

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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