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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Arm | All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine. |
| |
| Interview Arm | Interviews (with record taking) will take up to 2 hours to discuss barriers and facilitators to the administration of OZ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Questionnaires | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction and Treatment Persistence | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Barriers and Facilitators to Ocrevus Zunovo | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dylan Rice, B.A. | Contact | 312-503-5298 | dylan.rice@northwestern.edu | |
| Audrey Chang, B.A. | Contact | 312-503-8639 | audrey.chang@northwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi:10.1191/1478088706qp063oa. | ||
| 17872937 | Background | 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. | |
| 19664226 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2026 | Jul 13, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Semi-Structured Interviews | Other | Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes. |
|
| Quality of Life and Patient-Reported Outcomes | 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 |
| Background |
| 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. |
| 40975101 | Background | 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. |
| 40245351 | Background | 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. |
| 28002688 | Background | 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. |
| 28002679 | Background | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |