Ocrevus Zunovo for MS: Mixed Methods
16 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
The study 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.
The study 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.
Studietyp
Observationell
Inskrivning (Beräknad)
150
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Dylan Rice, B.A.
- Telefonnummer: 312-503-5298
- E-post: dylan.rice@northwestern.edu
Studera Kontakt Backup
- Namn: Audrey Chang, B.A.
- Telefonnummer: 312-503-8639
- E-post: audrey.chang@northwestern.edu
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Rekrytering
- Northwestern Memorial Hospital
-
Huvudutredare:
- Farrah J Mateen, MD, PhD
-
Kontakt:
- Dylan Rice, B.A.
- Telefonnummer: 312-503-5298
- E-post: dylan.rice@northwestern.edu
-
Kontakt:
- Audrey Chang, B.A.
- Telefonnummer: 312-503-8639
- E-post: audrey.chang@northwestern.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Clinical Arm
All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine.
|
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).
Ocrevus Zunovo (OZ) is a U.S. Food and Drug Administration-approved twice yearly subcutaneous injection, indicated for patients with relapsing and primary progressive multiple sclerosis (RMS and PPMS), given by a health care professional.
|
|
Interview Arm
Interviews (with record taking) will take up to 2 hours to discuss barriers and facilitators to the administration of OZ.
|
Semi-structured interviews will be conducted using an interview guide.
Interviews will be audio-recorded, transcribed, and documented via field notes.
Ocrevus Zunovo (OZ) is a U.S. Food and Drug Administration-approved twice yearly subcutaneous injection, indicated for patients with relapsing and primary progressive multiple sclerosis (RMS and PPMS), given by a health care professional.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Satisfaction and Treatment Persistence
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Barriers and Facilitators to Ocrevus Zunovo
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
- Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
- Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
- Montalban X, Lebrun-Frenay C, Oh J, Arrambide G, Moccia M, Pia Amato M, Amezcua L, Banwell B, Bar-Or A, Barkhof F, Butzkueven H, Ciccarelli O, Chataway J, Cohen JA, Comi G, Correale J, Deisenhammer F, Filippi M, Fiol J, Freedman MS, Fujihara K, Granziera C, Green AJ, Hartung HP, Hellwig K, Kappos L, Kimbrough D, Killestein J, Lublin F, Marignier R, Marrie RA, Miller A, Otero-Romero S, Ontaneda D, Ramanathan S, Reich D, Rocca MA, Rovira A, Saidha S, Salter A, Sastre-Garriga J, Saylor D, Solomon AJ, Sormani MP, Stankoff B, Tintore M, Tremlett H, Van der Walt A, Viswanathan S, Wiendl H, Wildemann B, Yamout B, Zaratin P, Calabresi PA, Coetzee T, Thompson AJ. Diagnosis of multiple sclerosis: 2024 revisions of the McDonald criteria. Lancet Neurol. 2025 Oct;24(10):850-865. doi: 10.1016/S1474-4422(25)00270-4.
- Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi:10.1191/1478088706qp063oa.
- Newsome SD, Krzystanek E, Selmaj KW, Dufek M, Goldstick L, Pozzilli C, Figueiredo C, Townsend B, Kletzl H, Bortolami O, Zecevic D, Giacobino C, Clinch S, Shen YA, Bhullar GD, Schneble HM, Centonze D. Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis: Results of the Phase 3 OCARINA II Study. Neurology. 2025 May 13;104(9):e213574. doi: 10.1212/WNL.0000000000213574. Epub 2025 Apr 17.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 juni 2026
Primärt slutförande (Beräknad)
1 december 2028
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 juli 2026
Första postat (Faktisk)
17 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2026
Senast verifierad
1 juli 2026
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU00226008
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