رادار التجارب AI | ||
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حالة التجربة السريرية NCT07207148 لـ التصلب المتعدد هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة نورث وسترنPeople With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists ١٠٠
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07207148 هي دراسة رصدية لـالتصلب المتعدد وهي يقبل مشاركين. بدأت في ٢٤ جمادى الأولى ١٤٤٧ هـ مع خطة لتجنيد ١٠٠ مشاركًا. يقودها جامعة نورث وسترن، ومن المتوقع اكتمالها بحلول ١٠ ربيع الآخر ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٨ رمضان ١٤٤٧ هـ.
الملخص
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...
عرض المزيدوصف مفصل
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...
عرض المزيدالعنوان الرسمي
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
الحالات الطبية
التصلب المتعددالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- STU00224018
NCT معرّف
تاريخ البدء (فعلي)
2025-11-15
آخر تحديث مُنشور
2026-03-17
تاريخ الاكتمال (المقدر)
2028-08-31
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
رصدية
الحالة
يقبل مشاركين
الكلمات الرئيسية
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
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
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...عرض المزيد | 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. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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. |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- 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.
جامعة نورث وسترن399 دراسات نشطة للاستكشافGenentech, Inc.الجهة المسؤولة عن الدراسة
Farrah Mateen, المحقق الرئيسي, Professor of Neurology, Northwestern University Feinberg School of Medicine
جهة اتصال مركزية للدراسة
جهة اتصال: Dylan Rice, BA, 240-362-4800, [email protected]
جهة اتصال: Caroline Gebczak, BS, 630-313-0470, [email protected]
1 مواقع الدراسة في 1 بلدان
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
Dylan Rice, BA, جهة اتصال, 240-362-4800, [email protected]
Caroline Gebczak, BS, جهة اتصال, 630-313-0470, [email protected]
Farrah J Mateen, MD, PhD, المحقق الرئيسي
يقبل مشاركين