Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728
- E-post: global-roche-genentech-trials@gene.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navn:
|
|
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. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navn:
|
|
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. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
Andre navn:
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MN46738
Plan for individuelle deltakerdata (IPD)
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