Recruiting

Ocrevus Zunovo

Sponsor:

Northwestern University

Code:

NCT07710105

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Questionnaires

Semi-Structured Interviews

Ocrevus Zunovo

Study Details

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

Study ID

NCT07710105

Start date

Jun 12, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Clinical Arm

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

Interview Arm

Interviews (with record taking) will take up to 2 hours to discuss barriers and facilitators to the administration of OZ.

Interventions

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).

Semi-Structured Interviews

Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.

Ocrevus Zunovo

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 outcome measure

  • Patient Satisfaction and Treatment Persistence [ Time Frame: From enrollment to 12-month follow-up visit ]

Central Contacts and Locations

Central contacts

Dylan Rice, B.A.

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

Audrey Chang, B.A.

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

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Dylan Rice, B.A.

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

Audrey Chang, B.A.

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

Principal Investigator:

Farrah J Mateen, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-20.