Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include: 1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality 2. EDSS (Expanded Disability Status Scale) 3. Cognition 4. Resource use 5. SPMS (Secondary Progressive Multiple Sclerosis) status 6. Employment history
Interventions
Telephone survey of all patients.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372) * Patient, caregiver, or legal guardian must provide written informed consent * Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo) | 20 years |
Countries
Canada, United States
Outcome results
None listed