Trial Condition(s):
Multiple Sclerosis
Telephone interview of patients that participated in the the Pivotal Betaferon MS trial.
Bayer Identifier:
14261
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham , United States, 35249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Maryland Baltimore , United States, 21201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUM - Hopital Notre-Dame Montreal, Canada, H2L 4M1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Neurologiques de Montreal Montreal, Canada, H3A 2B4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Health Sciences Centre London, Canada, N6A 5A5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Chicago Chicago, United States, 60637-1470 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, San Francisco San Francisco, United States, 94117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwest NeuroSpecialists, PLLC Tucson, United States, 85741-3537 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of British Columbia Hospital Vancouver, Canada, V6T 2B5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An observational 20-year, cross-sectional, long-term follow up of the patient cohort enrolled in the pivotal study of Betaseron® (interferon beta-1b) in relapsing-remitting multiple sclerosis
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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)Timeframe: 20 years
Additional Information
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