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NCT Number: NCT07710105

Ocrevus Zunovo for MS: Mixed Methods

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Patient Satisfaction and Treatment Persistence

    Time frame: 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.

Secondary outcomes

  1. Barriers and Facilitators to Ocrevus Zunovo

    Time frame: 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).

  2. Quality of Life and Patient-Reported Outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey Chang, B.A.

CONTACT

[email protected]

312-503-8639

Dylan Rice, B.A.

CONTACT

[email protected]

312-503-5298

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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