Ocrevus Zunovo for MS: Mixed Methods

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).
• Другое Semi-Structured Interviews
  Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.
• Препарат Ocrevus Zunovo
  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.

Первичные конечные точки

• Patient Satisfaction and Treatment Persistence [Срок оценки: From enrollment to 12-month follow-up visit]

Вторичные конечные точки (2)

• Barriers and Facilitators to Ocrevus Zunovo [Срок оценки: From enrollment to 12-month follow-up visit]
• Quality of Life and Patient-Reported Outcomes [Срок оценки: From enrollment to 12-month follow-up visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Northwestern Memorial Hospital — Chicago

Публикации

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• 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. PMID 17872937
• 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. PMID 19664226
• Montalban X, Lebrun-Frenay C, Oh J, Arrambide G, Moccia M, Amato MP, 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, Ram PMID 40975101
• 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. PMID 40245351
• 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: 10.10 PMID 28002688
• 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. PMID 28002679

Идентификаторы

NCT: NCT07710105 · STU00226008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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