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Ocrevus Zunovo for MS: Mixed Methods

13. juli 2026 opdateret af: Farrah Mateen, Northwestern University

Ocrevus Zunovo for Patients With Multiple Sclerosis: Mixed Methods on Barriers and Facilitators to Use and Retention

Ocrevus Zunovo implementation, feasibility, acceptability, patient satisfaction, treatment persistence, and impact on MS disease outcomes will be analyzed in this mixed methods study. This study will incorporate clinical data and questionnaire results from MS patients who take Ocrevus Zunovo as well as qualitative interviews with MS patients, family members, and other individuals involved in Ocrevus Zunovo treatment. The purpose of this study is to synthesize implementation strategies that improve patient access to high-efficacy MS therapies in real-world settings.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with MS who are clinically seen at the Northwestern Memorial Hospital system and are eligible for Ocrevus Zunovo (OZ) initiation may enroll in this study. OZ will be administered by the clinical infusion center.

We will enroll 50 OZ-treated MS patients over the course of 15-18 months, at approximately 4 patients per month. Participants will each be surveyed and followed at three main timepoints: (1) enrollment, as close as possible to the time of first OZ dosing, (2) 6 months of follow up, and (3) 12 months of follow up.

We will also conduct 100 semi-structured interviews, where facilitators and barriers will be recorded by patients, relevant stakeholders in their care and insurance billing, administrators, and clinical staff members.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Patients with MS who take OZ for their treatment are eligible. There must be a signed prescription for OZ for the MS patient. Patients who choose OZ will be offered dosing at Northwestern in the outpatient setting. Patients will be asked to complete assessments on demographic, clinical, and insurance-based factors at baseline, 6-, and 12-month visits. Patients will be invited to complete semi-structured interviews on these factors and their experiences.

Beskrivelse

Inclusion Criteria:

  • Age of 18 years or older
  • Resident of the USA
  • Seen at Northwestern Medicine
  • Meets diagnostic criteria (2024) for MS, either RMS or PPMS
  • Diagnosis of MS (G35) on file by a neurologist
  • Wants to start or restart a DMT for MS
  • Willing to be in a 12-month follow up study

Exclusion Criteria:

  • Unclear diagnosis of MS
  • Incarcerated
  • Unable to provide informed consent
  • Current participant in an MS or any experimental therapy clinical trial
  • Moribund
  • Unable to speak a language for which consent processes are available at Northwestern Hospitals
  • Currently taking a DMT that has not been washed out (e.g. recent treatment with Cladribine, Natalizumab, sphingosine 1-phosphate inhibitor, implying the last DMT is still actively immunosuppressing the patient)
  • Current chemotherapy
  • History of stem cell transplant, CAR-T or other chemo-ablative procedures
  • Unwilling to complete surveys over the course of the following 12 months
  • No access to computer or telephone
  • Prior allergic reaction or intolerance to Ocrelizumab IV or SubQ or any monoclonal antibody therapy
  • Hypogammaglobulinemia IgG level <500
  • Leukopenia <2.0
  • Active hepatitis or latent hepatitis B
  • Elevated liver enzymes 3 times the upper limit of normal
  • Tuberculosis
  • Current serious infection, e.g. COVID-19, shingles, active pneumonia, progressive multifocal leukoencephalopathy, etc.
  • Currently pregnant, breastfeeding, or a person of childbearing capacity who is sexually active without a documented plan of current contraceptive methods.
  • Any other diagnosis or reason deemed to make the participant unfit for participation by the study PI

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
Clinical Arm
All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine.
Andet: Clinical Questionnaires
Clinical course will be followed, including retention in treatment, patient-reported outcomes, and clinical events (new or incident demyelinating lesions on MRI or disease attacks).
Interview Arm
Interviews (with record taking) will take up to 2 hours to discuss barriers and facilitators to the administration of OZ.
Andet: Semi-Structured Interviews
Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Satisfaction and Treatment Persistence
Tidsramme: From enrollment to 12-month follow-up visit
For MS patients treated with OZ, to measure MS patient satisfaction and treatment persistence on Ocrevus at 6 and 12 months.
From enrollment to 12-month follow-up visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Barriers and Facilitators to Ocrevus Zunovo
Tidsramme: From enrollment to 12-month follow-up visit
To characterize barriers and facilitators of OZ prescribing by MS physicians using a rigorous qualitative approach across patients and other stakeholders in their care (family members, clinicians, pharmacy/infusion staff, care coordinators, administrators, and payer-facing staff).
From enrollment to 12-month follow-up visit
Quality of Life and Patient-Reported Outcomes
Tidsramme: From enrollment to 12-month follow-up visit
To determine the quality of life and patient-reported outcomes of people with MS treated with OZ at enrollment, 6 and 12 months.
From enrollment to 12-month follow-up visit

Samarbejdspartnere og efterforskere

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

Sponsor

Northwestern University

Samarbejdspartnere

Genentech, Inc.

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.

Generelle publikationer

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 (Faktiske)

12. juni 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU00226008

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Multipel sclerose

Kliniske forsøg med Clinical Questionnaires

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Croatia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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