Ocrevus Zunovo for MS: Mixed Methods

NCT07710105 | Recruiting FDA Drug

• 1 other identifier: STU00226008
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Ocrevus Zunovo; Ocrelizumab; Multiple Sclerosis; Disease-modifying therapy; Subcutaneous injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Barriers and Facilitators to Ocrevus Zunovo

  From enrollment to 12-month follow-up visit

• Quality of Life and Patient-Reported Outcomes

  From enrollment to 12-month follow-up visit

Study Arms (2)

Clinical Arm

All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine.

Other: Clinical Questionnaires; Drug: Ocrevus Zunovo

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; Drug: Ocrevus Zunovo

Interventions

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).

Clinical Arm

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.

Interview Arm

Ocrevus Zunovo DRUG

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.

Clinical Arm; Interview Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (7)

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  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.

  PMID: 17872937 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.

  PMID: 19664226 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.

  PMID: 40975101 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.

  PMID: 40245351 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.

  PMID: 28002688 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.

  PMID: 28002679 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dylan Rice, B.A.

CONTACT

312-503-5298; dylan.rice@northwestern.edu

Audrey Chang, B.A.

CONTACT

312-503-8639; audrey.chang@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Multiple Sclerosis and Neuroimmunology, Charles L. Mix Professor of Neurology Research

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)