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Ocrevus Zunovo for MS: Mixed Methods

NCT07710105 · Northwestern University
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Official title
Ocrevus Zunovo for Patients With Multiple Sclerosis: Mixed Methods on Barriers and Facilitators to Use and Retention
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.
Eligibility criteria
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 design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-06-12
Estimated completion: 2028-12
Last updated: 2026-07-20
Interventions
Other: Clinical QuestionnairesOther: Semi-Structured InterviewsDrug: Ocrevus Zunovo
Primary outcomes
  • Patient Satisfaction and Treatment Persistence (From enrollment to 12-month follow-up visit)
Sponsor
Northwestern University · other
With: Genentech, Inc.
Contacts & investigators
ContactDylan Rice, B.A. · contact · dylan.rice@northwestern.edu · 312-503-5298
ContactAudrey Chang, B.A. · contact · audrey.chang@northwestern.edu · 312-503-8639
All locations (1)
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Ocrevus Zunovo for MS: Mixed Methods · TrialPath