Ocrevus Zunovo for MS: Mixed Methods
2026年7月16日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dylan Rice, B.A.
- 电话号码：312-503-5298
- 邮箱：dylan.rice@northwestern.edu
研究联系人备份
- 姓名：Audrey Chang, B.A.
- 电话号码：312-503-8639
- 邮箱：audrey.chang@northwestern.edu
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60611
- 招聘中
- Northwestern Memorial Hospital
-
首席研究员：
- Farrah J Mateen, MD, PhD
-
接触：
- Dylan Rice, B.A.
- 电话号码：312-503-5298
- 邮箱：dylan.rice@northwestern.edu
-
接触：
- Audrey Chang, B.A.
- 电话号码：312-503-8639
- 邮箱：audrey.chang@northwestern.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Satisfaction and Treatment Persistence
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Barriers and Facilitators to Ocrevus Zunovo
大体时间：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).
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From enrollment to 12-month follow-up visit
|
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Quality of Life and Patient-Reported Outcomes
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月12日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月16日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STU00226008
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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