Ocrevus Zunovo for MS: Mixed Methods

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Clinical Questionnaires; Other: Semi-Structured Interviews

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Dylan Rice, B.A.; Phone Number: 312-503-5298; Email: dylan.rice@northwestern.edu
• Study Contact Backup: Name: Audrey Chang, B.A.; Phone Number: 312-503-8639; Email: audrey.chang@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Principal Investigator: Farrah J Mateen, MD, PhD
      • Contact: Dylan Rice, B.A.; Phone Number: 312-503-5298; Email: dylan.rice@northwestern.edu
      • Contact: Audrey Chang, B.A.; Phone Number: 312-503-8639; Email: audrey.chang@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinical Arm; All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine.	Other: 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.	Other: Semi-Structured Interviews; Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Genentech, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Ocrelizumab; Subcutaneous injection; Disease-modifying therapy; Ocrevus Zunovo
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: STU00226008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No