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Ocrevus Zunovo for MS: Mixed Methods

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "OZ will be administered by the clinical infusion center."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how Ocrevus Zunovo is used for multiple sclerosis (MS), how patients feel about it, whether they stay on treatment, and their health results. It is for adults with MS seen at Northwestern Medicine and uses health records, surveys, and interviews. The goal is to find ways to help patients get effective MS treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older and live in the United States.
  • You receive care at Northwestern Medicine.
  • You meet the 2024 rules for diagnosing relapsing MS or primary progressive MS, which steadily worsens.
  • A neurologist, a doctor who treats the brain and nerves, has recorded your MS diagnosis.
  • You want to start or restart a disease-modifying therapy (DMT), a medicine that changes the course of MS.
  • You are willing to take part in 12 months of follow-up.

Who can't join

  • Your MS diagnosis is unclear, you are in prison or jail, or you cannot give informed consent. You must speak a language in which Northwestern Hospitals offers the consent process.
  • You are in another MS study or a study of an experimental treatment, or your last MS medicine is still suppressing your immune system.
  • You are receiving chemotherapy, or have had a stem cell transplant, CAR-T cell therapy, or another treatment that destroys immune or bone marrow cells.
  • You will not complete surveys for 12 months, or you have no access to a computer or telephone.
  • You have had an allergic reaction to, or could not tolerate, ocrelizumab given by vein or under the skin, or any monoclonal antibody treatment.
  • You have low IgG antibodies (below 500), low white blood cells (below 2.0), or liver enzyme levels at least 3 times the upper limit of normal.
  • You have active hepatitis, inactive hepatitis B, tuberculosis, or a current serious infection, such as COVID-19, shingles, pneumonia, or PML, a serious brain infection.
  • You are pregnant or breastfeeding, or could become pregnant and are sexually active without a recorded birth control plan. You are near death, or the lead study doctor finds another reason you cannot safely take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

IL