Clinical trial NCT02433028: Swiss Multiple Sclerosis Cohort-Study
Official title: Swiss Multiple Sclerosis Cohort-Study: A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: MS key phases of disease evolution
MS New Treatment Options
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of Aarau, Switzerland
name: Cantonal Hospital of St. Gallen
name: Insel Gruppe AG, University Hospital Bern
name: Regional Hospital Lugano (EOC), Switzerland
name: University Hospital, Geneva
name: University of Lausanne Hospitals
name: National Multiple Sclerosis Society
First posted: 2015-05-04
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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.


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.

Primary outcomes:
measure: Assessment of Expanded Disability Status Scale (EDSS)
timeFrame: Baseline and at each follow-up visit (every 6 or 12 months)
measure: Assessment of the quality of life
timeFrame: Baseline and at least once a year
measure: Collection of serum and plasma (and, optional) cerebrospinal fluid samples
timeFrame: Baseline and at each follow-up visit (every 6 or 12 months)
measure: (Optional) Assessment of finger dexterity
timeFrame: Baseline and at each follow-up visit (every 6 or 12 months)
measure: (Optional) Electrophysiological assessment
timeFrame: Baseline and at each follow-up visit (every 6 or 12 months)
measure: (Optional) Laboratory tests
timeFrame: Baseline and at each follow-up visit (every 6 or 12 months)
measure: (Optional) Magnetic resonance imaging
timeFrame: Baseline and at least once per year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau
state: AG
city: Berne
country: Switzerland
facility: University Hospital Berne
state: BE
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
state: SG
city: Lugano
country: Switzerland
facility: Regional Hospital Lugano
state: TI
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
state: VD
city: Zürich
country: Switzerland
facility: Univeristy Hospital Zürich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Kuhle, MD
role: PRINCIPAL_INVESTIGATOR
References: