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RecruitingNCT02433028SMSCUpdated Apr 14, 2025

Swiss Multiple Sclerosis Cohort-Study

An observational study in Multiple Sclerosis, sponsored by University Hospital, Basel, Switzerland. Recruiting at 8 sites in Switzerland. Per ClinicalTrials.gov, last updated 2025-04-14.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Sex
All
01

Study 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.
02

Conditions studied

  • Multiple Sclerosis

Keywords

  • MS key phases of disease evolution
  • MS New Treatment Options
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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)

Eligibility criteria

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.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Assessment of Expanded Disability Status Scale (EDSS)

    Expanded Disability Status Scale (EDSS) is measured using Neurostatus by certified neurologists

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

  2. 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.

    Time frame: Baseline and at least once a year

  3. 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.

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

  4. (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.

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

  5. (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.

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

  6. (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

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

  7. (Optional) Magnetic resonance imaging

    The MRI is optional. All MRIs are collected that are done in clinical routine and follow the SMSC MRI protocol.

    Time frame: Baseline and at least once per year

06

Study locations

8 of 8 sites recruiting
  • Cantonal Hospital Aarau
    Aarau, AG 5001, Switzerland
    Recruiting
  • University Hospital Berne
    Berne, BE 3010, Switzerland
    • Robert Hoepner, MD · Contact · +416640067
    Recruiting
  • University Hospital Basel
    Basel, BS 4031, Switzerland
    Recruiting
  • University Hospital Geneva
    Geneva, GE 1211, Switzerland
    Recruiting
  • Cantonal Hospital St. Gallen
    St. Gallen, SG 9007, Switzerland
    Recruiting
  • Regional Hospital Lugano
    Lugano, TI 6900, Switzerland
    Recruiting
  • University Hospital Lausanne
    Lausanne, VD 1011, Switzerland
    Recruiting
  • Univeristy Hospital Zürich
    Zürich, Switzerland
    • Roth Patrick, Prof. Dr. · Contact · +41442555511
    • Miriam Kaminski, Dr. · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT02433028
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Cantonal Hospital of Aarau, Switzerland, Cantonal Hospital of St. Gallen, Insel Gruppe AG, University Hospital Bern, Regional Hospital Lugano (EOC), Switzerland, University Hospital, Geneva, University of Lausanne Hospitals, National Multiple Sclerosis Society
Responsible party
Sponsor
First posted
May 4, 2015
Start date
Jun 2012
Primary completion
Jan 2042 (estimated)
Completion
Jan 2042 (estimated)
Last update
Apr 14, 2025

Study contacts

Jens Kuhle, MD
Contact
jens.kuhle@usb.ch
0041612652525
Jens Kuhle, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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