Набор по приглашению NCT06167642

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

— Наблюдательное Multiple Sclerosis Tomography, Optical Coherence Retinal Degeneration Visual Acuity

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: Ofatumumab.
Кому может быть актуально: Состояния в реестре: Multiple Sclerosis, Tomography, Optical Coherence, Retinal Degeneration, Visual Acuity. Базовые параметры: 18 лет — 70 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis

Обзор

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

Подробное описание

Seventy-five people with RMS who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited. All recruited participants will be tracked prospectively over a two-year period. Participants will complete an optical coherence tomography (OCT) scan, visual acuity (VA) assessments, EDSS, and sNfL blood level at baseline and every 6 months. Participants will be tracked prospectively for 2 years. OCT scans, sNfL levels, disability score determinations, 100% high-contrast, 2.5% and 1.25% low-contrast letter acuities will be performed every 6 months. Results from an existing cohort of approximately 75 healthy controls (HC) from a separate study undergoing annual OCT and visual function assessments will be used for comparison purposes.

Вмешательства

Препарат Ofatumumab
Ofatumumab therapy is part of the patient's clinical care and is not given as part of the study

Первичные конечные точки

Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels [Срок оценки: at least 12 months for up to 2 years]

Вторичные конечные точки (4)

Inner nuclear layer (INL) atrophy in RMS relative to HCs [Срок оценки: at least 12 months for up to 2 years]
Outer nuclear layer (ONL) atrophy in RMS relative to HCs [Срок оценки: at least 12 months for up to 2 years]
Differences in the visual function scores [Срок оценки: at least 12 months for up to 2 years]
Differences in expanded disability status scale (EDSS) scores [Срок оценки: at least 12 months for up to 2 years]

Критерии участия

Критерии включения

Between 18 - 70 years of age
Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria

AND Either

be due to commence ofatumumab within 60 days of baseline OCT/VA/phlebotomy or
be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
Willing to sign informed consent
Willing to undergo phlebotomy