People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PIRA
研究概览
简要总结
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.
For Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.
For Aim 2, the clinical trial, PIRA will be measured pre-GLP-1 start and at study end (week 72). A composite score of disability, similar to the ORATORIO13 trial will be constructed including EDSS score, 25-foot timed walk, 9-hole peg test, and SDMT score.
详细描述
STUDY PROCEDURES:
Aim 1 will allow fully remote participation, drawing from geographically diverse settings throughout the USA. Participants in Aim 1 do not need to visit the study site in person or be independently mobile but must be continuously available during the study timeframe remotely for PROMS and study surveys and calls.
Participants will be enrolled for an estimated 72 weeks: Measurements will be requested every four weeks (i.e. q28 days) on a specifically designed survey instrument for MS participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, weight, height, and exercise activities. Self-reported scales will be administered to the participants as well (measuring disability, fatigue, mood, and quality of life).
Participants must be currently on Ocrelizumab (last dose within the past <6 months) and currently taking a GLP-1 medication.
Participants will be contacted and interviewed via Zoom every 6 months to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist,
- •Adult age 18-70 years,
- •BMI >=24.0 kg/m2,
- •Taken at least one dose of Ocrelizumab prior to study entry,
- •EDSS <7.0,
- •Able to provide individual informed consent,
- •MRI available to confirm the diagnosis of MS.
排除标准
- •Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
- •Current clinical trial participant,
- •Unable to speak a language for which translation can be found in the hospital system,
- •Unclear documentation of MS diagnosis or prior or current MS treatment,
- •Relapse within the past 3 months,
- •Recent major surgical procedure in the past 6 months,
- •Exposure to steroids (systemic) within the past 3 months,
- •Not on Ocrelizumab in the past >9 months,
- •Moribund status,
- •Underweight or experiencing protein malnutrition,
- •Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),
- •Unable to complete the study activities for any reason as deemed by the study investigator.
- •Additional Inclusion Criteria Aim 1:
- •Exposed to GLP-1 agonist treatment in the last 3 years or less, or starting on a GLP-1 agonist in the coming <3 months,
- •Willing to report monthly patient-reported outcomes remotely or in-person.
- •Additional Inclusion Criteria Aim 2:
- •Able to present for baseline and follow up in person,
- •Unexposed to a GLP-1 agonist in the past year,
- •Starting on a GLP-1 agonist in the next <6 months,
- •Plan to be exposed to GLP-1 agonist for a minimum of 72 weeks following enrollment.
研究组 & 干预措施
Aim 1
The cohort will implement patient-reported outcome measures (PROMs) in 60 people with MS already treated with both Ocrelizumab and a GLP-1 agonist to assess progression and ambulation, while recording drug tolerability and potential adverse events, weight loss, disease-based outcomes focused on progression, and MS-focused quality of life.
干预措施: Ocrelizumab (US) (Drug)
Aim 2
The cohort will include a single-arm, open-label trial of 40 Ocrelizumab-treated MS patients who are soon starting GLP-1 agonists, monitored prospectively for 2 years to measure MS progression (clinical disability worsening, stability or improvement) every 3 months, including (a) clinical assessments (e.g. EDSS, 25-foot timed walk, SDMT) as used in the ORATORIO trial of Ocrelizumab, (b) PROMs on progression in MS including fatigue, ambulation distance, mood; and (3) simple objective biomarkers of disease (e.g. plasma neurofilament light chain, glial fibrillary acidic protein).
干预措施: Ocrelizumab (US) (Drug)
Aim 2
The cohort will include a single-arm, open-label trial of 40 Ocrelizumab-treated MS patients who are soon starting GLP-1 agonists, monitored prospectively for 2 years to measure MS progression (clinical disability worsening, stability or improvement) every 3 months, including (a) clinical assessments (e.g. EDSS, 25-foot timed walk, SDMT) as used in the ORATORIO trial of Ocrelizumab, (b) PROMs on progression in MS including fatigue, ambulation distance, mood; and (3) simple objective biomarkers of disease (e.g. plasma neurofilament light chain, glial fibrillary acidic protein).
干预措施: GLP-1 (Drug)
Aim 1
The cohort will implement patient-reported outcome measures (PROMs) in 60 people with MS already treated with both Ocrelizumab and a GLP-1 agonist to assess progression and ambulation, while recording drug tolerability and potential adverse events, weight loss, disease-based outcomes focused on progression, and MS-focused quality of life.
干预措施: GLP-1 (Drug)
结局指标
主要结局
PIRA
时间窗: From enrollment to the end of study at 72 weeks.
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.
次要结局
- Neurofilament light chain(From the start of Aim 2 to the end of treatment at 72 weeks.)
研究者
Farrah Mateen
Professor of Neurology
Northwestern University Feinberg School of Medicine