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Идёт набор NCT05962177

Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic

Без фазы С лечением Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Magnetic Resonance Imaging, Blood withdrawal, Neuropsychological tests.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 59 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients \> 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data. The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients. The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed. Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc. It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible. This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS). The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).

Подробное описание

Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET : Natalizumab, Fingolimod, Ocrelizumab, Rituximab, Ofatumumab, Cladribine) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET : Beta interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients \> 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.

The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.

The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.

Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.

It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.

This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).

The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).

3 groups of interest will be studied and included in the study:

* Group 1: RRMS with medium efficacy treatment (interferon beta, glatiramer acetate, Teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease (n=175 patients) * Group 2: RRMS with high efficacy treatment (Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod, Cladribine: n=175 patients) * Group 3: Untreated RRMS (n=50 patients)

Вмешательства

  • Другое Magnetic Resonance Imaging
    Magnetic Resonance Imaging
  • Другое Blood withdrawal
    Blood withdrawal
  • Другое Neuropsychological tests
    Neuropsychological tests

Первичные конечные точки

  • Total brain atrophy [Срок оценки: 3 years after Day 1]
Вторичные конечные точки (12)
  • Quantitative analysis: analysis of FLAIR hypersignals number [Срок оценки: 3 years after Day 1]
  • Quantitative analysis: analysis of FLAIR hypersignals volume [Срок оценки: 3 years after Day 1]
  • Qualitative analysis: analysis of central vein lesions [Срок оценки: 3 years after Day 1]
  • Qualitative analysis: analysis of peripheral rim lesion [Срок оценки: 3 years after Day 1]
  • Quantitative analysis: measurement of mean diffusivity [Срок оценки: 3 years after Day 1]
  • Quantitative analysis: measurement of anisotropy fraction [Срок оценки: 3 years after Day 1]
  • Quantitative analysis: measurement of cerebral blood flow (CBF) [Срок оценки: 3 years after Day 1]
  • Changes in serum light chain neurofilament values [Срок оценки: 3 years after Day 1]
  • Clinical assessment scale: relapses [Срок оценки: 3 years after Day 1]
  • Clinical assessment scale: Expanded Disability Status Scale (EDSS) [Срок оценки: 3 years after Day 1]
  • Clinical assessment scale: Computerized Speed Cognitive Test (CSCT) [Срок оценки: 3 years after Day 1]
  • Clinical assessment scale: Six-Minute Walk Test (6MWT) [Срок оценки: 3 years after Day 1]

Критерии участия

Критерии включения

  • Patients over 18 and under 60 years of age
  • Patients with Relapsing-remitting MS without relapse for at least 6 months
  • EDSS<6 at time of inclusion

Критерии исключения

  • Secondary progressive MS or Primary progressive MS at time of inclusion
  • Evidence of disease progression (clinical or radiological)
  • Change in treatment within 6 months prior to inclusion
  • Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.)
  • Inability to follow the follow-up planned by the study
  • Pregnant or breastfeeding women
  • Patient not affiliated to the social security system or not benefiting from such a system
  • Adult protected by law or patient under guardianship or curatorship
  • Failure to obtain written informed consent after a reflection period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Neurology Department, Hopital Gui de Chauliac — Montpellier

Идентификаторы

NCT: NCT05962177 · RECHMPL20_0422

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗