Идёт набор NCT06780150

A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)

— Наблюдательное 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: Ocrelizumab.
Кому может быть актуально: Состояния в реестре: Multiple Sclerosis. Базовые параметры: от 18 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: Германия, Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis

Обзор

The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).

Вмешательства

Препарат Ocrelizumab
Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.

Первичные конечные точки

Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC [Срок оценки: Month 12]

Вторичные конечные точки (12)

Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC [Срок оценки: Baseline, Month 6]
Change From Baseline in NfL Protein Levels in Serum [Срок оценки: Baseline, Month 6, Month 12]
Concentration of NfL Protein Levels in Serum [Срок оценки: Baseline, Month 6, Month 12]
Correlation Between NfL Protein Levels in Serum With MS Relapse [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS) [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT) [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI] [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count [Срок оценки: Up to Month 12]
Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels [Срок оценки: Up to Month 12]

Критерии участия

Критерии включения

Diagnosis of MS
RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024
First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab

Критерии исключения

Participation in interventional studies investigating DMTs for MS
Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site
Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)
Severe psychiatric disability
Pregnant women

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

Здоровые добровольцы: Нет