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Trial record 1 of 1 for:    NCT02433028
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Swiss Multiple Sclerosis Cohort-Study (SMSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02433028
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : April 7, 2023
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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
Multiple Sclerosis

Study Design
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Study Type : Observational
Estimated 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 : June 2012
Estimated Primary Completion Date : January 2042
Estimated Study Completion Date : January 2042

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change in assessment of Expanded Disability Status Scale (EDSS) [ Time Frame: every 6 or 12 months, up to 10 years ]
    assessment of Expanded Disability Status Scale


Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinically isolated Syndrome, Radiologically isolated syndrome, Multiple Sclerosis, Devic Syndrome
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433028


Contacts
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Contact: Jens Kuhle, MD 0041612652525 jens.kuhle@usb.ch
Contact: Vanessa Valleja, Dr. 004161556 5251 vanessa.valleja@usb.ch

Locations
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Switzerland
Cantonal Hospital Aarau Recruiting
Aarau, AG, Switzerland, 5001
Contact: Lutz Achtnichts, MD    0041 62 838 94 69    lutz.achtnichts@ksa.ch   
Contact: Jaqueline Saxer       jaqueline.saxer@ksa.ch   
University Hospital Berne Recruiting
Berne, BE, Switzerland, 3010
Contact: Anke Salmen, MD       anke.salmen@insel.ch   
Contact: Monika Käser       monika.kaeser@insel.ch   
University Hospital Basel Recruiting
Basel, BS, Switzerland, 4031
Contact: Jens Kuhle, MD    0041612652525    jens.kuhle@usb.ch   
Contact: Vanessa Valleja, Dr.    004161556 5251    vanessa.valleja@usb.ch   
University Hospital Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Patrice Lalive, MD    0041 22 379 46 98    patrice.lalivedepinay@unige.ch   
Contact: Ninon Seiko Horie, MD       ninon.seiko.horie@hcuge.ch   
Cantonal Hospital St. Gallen Recruiting
St. Gallen, SG, Switzerland, 9007
Contact: Stefanie Mueller, MD    0041 71 494 11 11    stefanie.mueller@kssg.ch   
Regional Hospital Lugano Recruiting
Lugano, TI, Switzerland, 6900
Contact: Claudio Gobbi, MD    0041 91 811 69 21    claudio.gobbi@eoc.ch   
University Hospital Lausanne Recruiting
Lausanne, VD, Switzerland, 1011
Contact: Myriam Schluep, MD    0041 21 314 12 69    myriam.schluep@chuv.ch   
Contact: Renaud Du-Pasquier, MD       renaud.du-pasquier@chuv.ch   
Univeristy Hospital Zürich Recruiting
Zürich, Switzerland
Contact: Roland Martin, Prof. Dr. MD       roand.martin@usz.ch   
Contact: Magdalena Foege, Dr., MD       magdalena.foege@usz.ch   
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
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Principal Investigator: Jens Kuhle, MD University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02433028    
Other Study ID Numbers: SMSC_1_3
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: April 7, 2023
Last Verified: April 2023
Keywords provided by University Hospital, Basel, Switzerland:
MS key phases of disease evolution
MS New Treatment Options
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases