Ocrevus Zunovo for Patients With Multiple Sclerosis: Mixed Methods on Barriers and Facilitators to Use and Retention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient Satisfaction and Treatment Persistence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unclear diagnosis of MS
- •Incarcerated
- •Unable to provide informed consent
- •Current participant in an MS or any experimental therapy clinical trial
- •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
研究组 & 干预措施
Clinical Arm
All enrolled OZ-treated MS participants will have at least one clinical inpatient visit at Northwestern Medicine.
干预措施: Clinical Questionnaires (Other)
Interview Arm
Interviews (with record taking) will take up to 2 hours to discuss barriers and facilitators to the administration of OZ.
干预措施: Semi-Structured Interviews (Other)
结局指标
主要结局
Patient Satisfaction and Treatment Persistence
时间窗: 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.
次要结局
- Barriers and Facilitators to Ocrevus Zunovo(From enrollment to 12-month follow-up visit)
- Quality of Life and Patient-Reported Outcomes(From enrollment to 12-month follow-up visit)
研究者
Farrah Mateen
Division Chief of Multiple Sclerosis and Neuroimmunology, Charles L. Mix Professor of Neurology Research
Northwestern University