Swiss Multiple Sclerosis Cohort-Study

Multiple Sclerosis Clinical Trial

— SMSC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433028
• Other study ID #: SMSC_1_3
• Status: Recruiting
• Start date: June 2012
• Est. completion date: January 2042

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Jens Kuhle, MD
• Phone: 0041612652525
• Email: jens.kuhle[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 2042
• Est. primary completion date: January 2042
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Aarau	Aarau	AG
Switzerland	University Hospital Basel	Basel	BS
Switzerland	University Hospital Berne	Berne	BE
Switzerland	University Hospital Geneva	Geneva	GE
Switzerland	University Hospital Lausanne	Lausanne	VD
Switzerland	Regional Hospital Lugano	Lugano	TI
Switzerland	Cantonal Hospital St. Gallen	St. Gallen	SG
Switzerland	Univeristy Hospital Zürich	Zürich

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Cantonal Hospital of Aarau, Switzerland, Cantonal Hospital of St. Gallen, Insel Gruppe AG, University Hospital Bern, National Multiple Sclerosis Society, Regional Hospital Lugano (EOC), Switzerland, University Hospital, Geneva, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Expanded Disability Status Scale (EDSS)	Expanded Disability Status Scale (EDSS) is measured using Neurostatus by certified neurologists	Baseline and at each follow-up visit (every 6 or 12 months)
Primary	Assessment of the quality of life	To assess the quality of life, the following patient-reported outcomes are collected: Multiple Sclerosis Quality of Life-54: A self-report questionnaire regarding quality of life with 36 generic (which corresponds to the 36 items of the Short-Form-36 questionnaire) and 18 MS-specific items.; EuroQoL-5D: A self-report questionnaire on generic quality of life, with one question for each of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a Visual Analog Scale regarding perceived health status, ranging from 0 (worst possible) to 100 (best possible).; Patient reported questionnaire: Includes questions regarding professional activity and changes, and hospitalization.	Baseline and at least once a year
Primary	Collection of serum and plasma (and, optional) cerebrospinal fluid samples	Serum and plasma samples will be collected every 6 or 12 months for all participants during study visit. Cerebrospinal fluid samples are facultative and contribute only if the participant is undergoing a diagnostic lumbar puncture.	Baseline and at each follow-up visit (every 6 or 12 months)
Primary	(Optional) Assessment of finger dexterity	To assess the finger dexterity, the 9-Hole Peg Test is performed. It evaluates manual dexterity by measuring the time it takes for the participant to move nine pegs from a box into nine holes on a board and back. The 9-Hole Peg Test is not mandatory and is performed at the discretion of the physician.	Baseline and at each follow-up visit (every 6 or 12 months)
Primary	(Optional) Electrophysiological assessment	To measure the visual, sensory and motor conduction time in the CNS, evoked potential tests are performed. Evoked Potentials are not mandatory and is performed at the discretion of the physician.	Baseline and at each follow-up visit (every 6 or 12 months)
Primary	(Optional) Laboratory tests	The following laboratory tests are not mandatory, but are routinely performed in patients with MS at the discretion of the physician: Anti-JCV antibody test; Anti-natalizumab antibody test; Lymphocyte count	Baseline and at each follow-up visit (every 6 or 12 months)
Primary	(Optional) Magnetic resonance imaging	The MRI is optional. All MRIs are collected that are done in clinical routine and follow the SMSC MRI protocol.	Baseline and at least once per year