Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
- Registration Number
- NCT01031459
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
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
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Betaseron (Interferon beta-1b, BAY86-5046) -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method