Swiss Multiple Sclerosis Cohort-Study

NCT02433028 | Recruiting

• 1 other identifier: SMSC_1_3
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 8

Brief 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. 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. 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.
3. 3.Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response.
4. 4.Exploration of the safety and impact on long-term disability of existing and next generation MS treatments
5. 5.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.
6. 6.Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.

Conditions

Multiple Sclerosis

Keywords

MS key phases of disease evolution; MS New Treatment Options

Outcome Measures

Primary Outcomes (7)

• 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)

• 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

• 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)

• (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)

• (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)

• (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)

• (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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of radiologically isolated syndrome (RIS), clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), neuromyelitis optica spectrum disorder (NMOSD) or Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

You may qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Cantonal Hospital of Aarau, Switzerland: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Regional Hospital Lugano (EOC), Switzerland: collaborator
• University Hospital, Geneva: collaborator
• University of Lausanne Hospitals: collaborator
• National Multiple Sclerosis Society: collaborator

Study Sites (8)

Cantonal Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

University Hospital Berne

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Regional Hospital Lugano

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Univeristy Hospital Zürich

Zurich, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jens Kuhle, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Kuhle, MD

CONTACT

0041612652525; jens.kuhle@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: May 4, 2015
• Study Start: June 1, 2012
• Primary Completion (Estimated): January 1, 2042
• Study Completion (Estimated): January 1, 2042
• Last Updated: April 14, 2025

Record last verified: 2025-04

Locations

CH (8)