Ocrevus Zunovo for MS: Mixed Methods
Recruiting · NCT07710105 · Observational (researchers observe without assigning treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →Interventions studied
Clinical QuestionnairesOcrevus ZunovoSemi-Structured Interviews
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Northwestern Memorial Hospital - Chicago, Illinois, United States