Swiss Multiple Sclerosis Registry

Multiple Sclerosis Clinical Trial

— SMSR  

Official title:

Swiss Multiple Sclerosis Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980640
• Other study ID #: PB_2016-00894
• Status: Recruiting
• Start date: June 2016
• Est. completion date: June 2041

Study information

• Verified date: April 2024
• Source: Swiss Multiple Sclerosis Registry
• Contact: Milo Puhan, MD PhD
• Phone: ++41 (0)44 634 4610
• Email: miloalan.puhan[@]uzh.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of persons living with MS in Switzerland.

Description:

The Swiss Multiple Sclerosis Registry is a national, patient-centered research project with the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of persons living with MS in Switzerland. The Swiss MS Registry pursues a "Citizen Science" approach, that is, persons with MS are not just study participants but also act as MS experts and are active contributors to the interdisciplinary Swiss MS Registry research network. Initiated and funded by the Swiss MS Society, the Swiss MS Registry represents a collaborative effort by numerous MS caregivers, researchers and persons with MS. It is hosted by the Epidemiology, Biostatistics and Prevention Institute at the University of Zurich. How many MS-affected persons are living in Switzerland and how are they coping with MS in their daily lives? What is the current situation with regard to access to and use of drug and non-drug treatments for MS? These and other questions are addressed by means of semi-annual surveys. Further research activities concern the quality of life of persons with MS, mobility, personal resources and support by friends and family, work situation, mental health, clinical progression of MS, as well as alternative therapies. Owing to a flexible study design, participants can decide between different levels of commitment (from one-time surveys to repeated, semiannual surveys and medical records review). Furthermore, study participants receive summaries of their data as charts and tables. Data collection primarily occurs via a newly designed online platform, but paper-and-pencil questionnaires are also available. As an additional incentive, the online platform includes a diary with basic capabilities for analyses and printing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 2041
• Est. primary completion date: June 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons with a confirmed Multiple Sclerosis Diagnosis
• 18 years and older
• Living in Switzerland or receiving MS care in Switzerland

Exclusion Criteria:

• Younger than 18 years
• Not living in Switzerland and not receiving MS care in Switzerland

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	University of Zurich; Epidemiology, Biostatistics & Prevention Institute	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Multiple Sclerosis Registry	Schweizerische Multiple Sklerose Gesellschaft, University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health-Related Quality of Life	Assessment via EQ-5D	Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Primary	Change in Self-Assessment of Health Status	Assessment via Visual Analogue Scale	Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Secondary	Occurrence of MS Symptoms	Self-report of new and recurrent MS symptoms	Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Secondary	Occurrence of Adverse Drug Effects	Self-report of unwanted drug side effects	Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Secondary	Occurrence of MS Relapse	Self-report of MS relapse(s)	Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

External Links

•   Description of main study design of the Swiss Multiple Sclerosis Registry
•   Description of Swiss MS Registry in French
•   Description of Swiss MS Registry in German
•   Description of Swiss MS Registry in Italian
•   Protocol Description of the Swiss Multiple Sclerosis Registry