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임상시험 NCT07207148은(는) 다발성 경화증에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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노스웨스턴 대학교People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists 100
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07207148은(는) 다발성 경화증에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2025년 11월 15일에 시작되어 100명의 참여자를 모집하고 있습니다. 노스웨스턴 대학교이(가) 진행하며, 2028년 8월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 17일에 갱신되었습니다.
간단한 개요
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 sco...
더 보기상세한 설명
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 request...
더 보기공식 제목
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
질환명
다발성 경화증출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- STU00224018
NCT 번호
실제 연구 시작일
2025-11-15
최신 업데이트 게시
2026-03-17
예상 연구 완료일
2028-08-31
계획된 등록 인원
100
연구종류
관찰연구
상태
모집중
키워드
Ocrelizumab
GLP-1
Obesity
Weight loss
Progressive MS
Multiple sclerosis
Biomarkers
Weight
Overweight
Neuroprotection
Semaglutide
glucagon-like peptide-1
GLP-1
Obesity
Weight loss
Progressive MS
Multiple sclerosis
Biomarkers
Weight
Overweight
Neuroprotection
Semaglutide
glucagon-like peptide-1
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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. | GLP-1 Glucagon-like peptide-1 agonist agent is the study agent of interest. This study will not supply the GLP-1 drug but depends on the patient's clinical prescription of this drug. Ocrelizumab (US) All participants will be treated with Ocrelizumab for the indication of MS; however, the study will not provide Ocrelizumab as it will be part of the participant's routine clinical care. |
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 inc...더 보기 | GLP-1 Glucagon-like peptide-1 agonist agent is the study agent of interest. This study will not supply the GLP-1 drug but depends on the patient's clinical prescription of this drug. Ocrelizumab (US) All participants will be treated with Ocrelizumab for the indication of MS; however, the study will not provide Ocrelizumab as it will be part of the participant's routine clinical care. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
PIRA | The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. | From enrollment to the end of study at 72 weeks. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Neurofilament light chain | There will be blood draws in Aim 2's clinical trial population. Aim 1's observational, interactive cohort will have an optional blood draw component. In both cases, the blood tests will involve send out testing for neurofilament light chain and in Aim 2, glial fibrillary acidic protein. | From the start of Aim 2 to the end of treatment at 72 weeks. |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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.
- 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.
노스웨스턴 대학교399개의 진행 중인 임상시험 탐색 가능Genentech, Inc.연구 책임자
Farrah Mateen, 책임연구자, Professor of Neurology, Northwestern University Feinberg School of Medicine
연구 대표 연락처
연락처: Dylan Rice, BA, 240-362-4800, [email protected]
연락처: Caroline Gebczak, BS, 630-313-0470, [email protected]
1 1개국에 임상시험 장소
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
Dylan Rice, BA, 연락처, 240-362-4800, [email protected]
Caroline Gebczak, BS, 연락처, 630-313-0470, [email protected]
Farrah J Mateen, MD, PhD, 책임연구자
모집중