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SMSC: Swiss Multiple Sclerosis Cohort-Study

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT02433028
Collaborator
Cantonal Hospital of Aarau, Switzerland (Other), Cantonal Hospital of St. Gallen (Other), University Hospital Inselspital, Berne (Other), Regional Hospital Lugano (EOC), Switzerland (Other), University Hospital, Geneva (Other), University of Lausanne Hospitals (Other), National Multiple Sclerosis Society (Other)
1,200
Enrollment
8
Locations
355
Duration (Months)
150
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The key aims of the Swiss Multiple Sclerosis Cohort-Study (SMSC) are

  1. To maintain a long-term cohort (>10 years) representative of the MS population currently living 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 multiple sclerosis (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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Swiss Multiple Sclerosis Cohort-Study: A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options
    Study Start Date :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2042
    Anticipated Study Completion Date :
    Jan 1, 2042

    Outcome Measures

    Primary Outcome Measures

    1. Change in assessment of Expanded Disability Status Scale (EDSS) [every 6 or 12 months, up to 10 years]

      assessment of Expanded Disability Status Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. without immunomodulatory treatment (DMD) or

    2. starting a DMD

    3. already treated with Tysabri® or Gilenya®

    4. switching a DMD or indication for switching DMD.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cantonal Hospital Aarau Aarau AG Switzerland 5001
    2 University Hospital Berne Berne BE Switzerland 3010
    3 University Hospital Basel Basel BS Switzerland 4031
    4 University Hospital Geneva Geneva GE Switzerland 1211
    5 Cantonal Hospital St. Gallen St. Gallen SG Switzerland 9007
    6 Regional Hospital Lugano Lugano TI Switzerland 6900
    7 University Hospital Lausanne Lausanne VD Switzerland 1011
    8 Univeristy Hospital Zürich Zürich Switzerland

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland
    • Cantonal Hospital of Aarau, Switzerland
    • Cantonal Hospital of St. Gallen
    • University Hospital Inselspital, Berne
    • Regional Hospital Lugano (EOC), Switzerland
    • University Hospital, Geneva
    • University of Lausanne Hospitals
    • National Multiple Sclerosis Society

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT02433028
    Other Study ID Numbers:
    • SMSC_1_3
    First Posted:
    May 4, 2015
    Last Update Posted:
    Jan 31, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by University Hospital, Basel, Switzerland
    MS key phases of disease evolution
    MS New Treatment Options
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jan 31, 2020