Multiple Sclerosis
Conditions
Keywords
Ocrevus Zunovo, Ocrelizumab, Multiple Sclerosis, Disease-modifying therapy, Subcutaneous injection
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.
Detailed description
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.
Interventions
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).
OTHERSemi-Structured Interviews
Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.
DRUGOcrevus 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.
Sponsors
Northwestern University
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction and Treatment Persistence | 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
| Measure | Time frame | Description |
|---|---|---|
| Barriers and Facilitators to Ocrevus Zunovo | 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). |
| Quality of Life and Patient-Reported Outcomes | 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. |
Countries
United States
Contacts
CONTACTDylan Rice, B.A.
CONTACTAudrey Chang, B.A.
Outcome results
None listed