Multiple SclerosisSMSCNCT02433028
Swiss Multiple Sclerosis Cohort-Study
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,200 participants
- Where
- 8 sitesSwitzerland
- Study dates
- Jun 2012to Jan 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Switzerland8 sites, 8 recruiting
- Recruiting
Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
Oliver Findling, MD, +41628389469
Jaqueline Saxer, jaqueline.saxer@ksa.ch
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City, 4031
Jens Kuhle, MD, +41612652525, jens.kuhle@usb.ch
- Recruiting
University Hospital Berne
Bern, Canton of Bern, 3010
Robert Hoepner, MD, +416640067
- Recruiting
University Hospital Geneva
Geneva, Canton of Geneva, 1211
Patrice Lalive, MD, +41223728318, Patrice.Lalive@hcuge.ch
- Recruiting
University Hospital Lausanne
Lausanne, Canton of Vaud, 1011
Caroline Pot, MD, +41213141269, Caroline.Pot-Kreis@chuv.ch
Renaud Du-Pasquier, MD, renaud.du-pasquier@chuv.ch
- Recruiting
Regional Hospital Lugano
Lugano, Canton Ticino, 6900
Claudio Gobbi, MD, +41918116921, claudio.gobbi@eoc.ch
- Recruiting
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Stefanie Mueller, MD, +41714941111, stefanie.mueller@kssg.ch
Jochen Vehoff, Dr.
- Recruiting
Univeristy Hospital Zürich
Zurich
Roth Patrick, Prof. Dr., +41442555511
Miriam Kaminski, Dr.
About this study
Official title: 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
- 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
- To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids.
Read more
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:
- Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response.
- Exploration of the safety and impact on long-term disability of existing and next generation MS treatments
- 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.
- 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
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) is measured using Neurostatus by certified neurologists
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and at least once per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJun 2012
- Primary completionJan 2042 (estimated)
- Study completionJan 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Jens Kuhle, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433028
- Sponsor's protocol ID
- SMSC_1_3
- Acronym
- SMSC
- Status last verified
- Apr 2025
- First submitted
- 18 Dec 2014
- Last updated
- 14 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Multiple Sclerosis Cohort-Study: A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options
- ClinicalTrials.gov ID
- NCT02433028
- Acronym / sponsor ID
- SMSC / SMSC_1_3
- Conditions
- Multiple Sclerosis
- Keywords
- MS key phases of disease evolution, MS New Treatment Options
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- 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
- Study start
- Jun 2012 (actual)
- Primary completion
- Jan 2042 (estimated)
- Study completion
- Jan 2042 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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:
- Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response.
- Exploration of the safety and impact on long-term disability of existing and next generation MS treatments
- 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.
- Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
(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.
(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.
(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
(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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Kuhle, MD principal investigator
University Hospital, Basel, Switzerland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Kuhle, MD (0041612652525, jens.kuhle@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Expanded Disability Status Scale (EDSS) (time frame: Baseline and at each follow-up visit (every 6 or 12 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2025.