Swiss Multiple Sclerosis Cohort-Study (SMSC)

April 9, 2024 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zürich, Switzerland
        • Recruiting
        • Univeristy Hospital Zürich
        • Contact:
          • Roth Patrick, Prof. Dr.
          • Phone Number: +41442555511
        • Contact:
          • Miriam Kaminski, Dr.
    • AG
      • Aarau, AG, Switzerland, 5001
        • Recruiting
        • Cantonal Hospital Aarau
        • Contact:
          • Oliver Findling, MD
          • Phone Number: +41628389469
        • Contact:
    • BE
      • Berne, BE, Switzerland, 3010
        • Recruiting
        • University Hospital Berne
        • Contact:
          • Robert Hoepner, MD
          • Phone Number: +416640067
    • BS
      • Basel, BS, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
    • GE
      • Geneva, GE, Switzerland, 1211
        • Recruiting
        • University Hospital Geneva
        • Contact:
    • SG
      • St. Gallen, SG, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St. Gallen
        • Contact:
        • Contact:
          • Jochen Vehoff, Dr.
    • TI
      • Lugano, TI, Switzerland, 6900
        • Recruiting
        • Regional Hospital Lugano
        • Contact:
    • VD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Expanded Disability Status Scale (EDSS)
Time Frame: Baseline and at each follow-up visit (every 6 or 12 months)
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
Time Frame: Baseline and at least once a year

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
Time Frame: Baseline and at each follow-up visit (every 6 or 12 months)
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
Time Frame: Baseline and at each follow-up visit (every 6 or 12 months)
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
Time Frame: Baseline and at each follow-up visit (every 6 or 12 months)
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
Time Frame: Baseline and at each follow-up visit (every 6 or 12 months)

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
Time Frame: Baseline and at least once per year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

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

Investigators

  • Principal Investigator: Jens Kuhle, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Estimated)

January 1, 2042

Study Completion (Estimated)

January 1, 2042

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimated)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMSC_1_3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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