Swiss Multiple Sclerosis Cohort-Study

Официальное название

Swiss Multiple Sclerosis Cohort-Study: A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options

Обзор

The Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are 1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and 2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids. The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data. Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the: 1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response. 2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments 3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it. 4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.

Первичные конечные точки

• Assessment of Expanded Disability Status Scale (EDSS) [Срок оценки: Baseline and at each follow-up visit (every 6 or 12 months)]
• Assessment of the quality of life [Срок оценки: Baseline and at least once a year]
• Collection of serum and plasma (and, optional) cerebrospinal fluid samples [Срок оценки: Baseline and at each follow-up visit (every 6 or 12 months)]
• (Optional) Assessment of finger dexterity [Срок оценки: Baseline and at each follow-up visit (every 6 or 12 months)]
• (Optional) Electrophysiological assessment [Срок оценки: Baseline and at each follow-up visit (every 6 or 12 months)]
• (Optional) Laboratory tests [Срок оценки: Baseline and at each follow-up visit (every 6 or 12 months)]
• (Optional) Magnetic resonance imaging [Срок оценки: Baseline and at least once per year]

Критерии участия

Критерии включения

• Fulfilling the diagnosis of radiologically isolated syndrome (RIS), clinically isolated syndrome (CIS), relapsing-remitting Multiple Sclerosis (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), neuromyelitis optica spectrum disorder (NMOSD) or Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) according to established criteria
• Intending to attend hospital visits every 6 months (+/- 45 days) or 12 months (+/- 45 days) (facultative cranial MRI every 12 months) over a longer period (at least 5 years)
• Intending to give blood for biobanking every 6 or 12 months during hospital visit or as close as possible to the visit (+/- 8 days)

Inclusion criteria are crafted to identify a population of patients with MS, NMOSD or MOGAD particularly suitable for analysing disease evolution and associated factors, treatment dynamics, and the long-term safety and efficacy profile of disease-modifying drugs.

There are no specific Exclusion Criteria.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 8 центров

• Cantonal Hospital Aarau — Aarau
• University Hospital Basel — Basel
• University Hospital Berne — Bern
• University Hospital Geneva — Geneva
• Cantonal Hospital St. Gallen — Sankt Gallen
• University Hospital Lausanne — Lausanne
• Regional Hospital Lugano — Lugano
• Univeristy Hospital Zürich — Zurich

Идентификаторы

NCT: NCT02433028 · SMSC_1_3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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