Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
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
2 other identifiers
observational
176
2 countries
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 5, 2012
January 1, 2012
11 months
December 8, 2009
January 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Group 1
Interventions
Eligibility Criteria
Patients with MS that participated in the 16Y-LTF and Pivitol studies
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (10)
Unknown Facility
Birmingham, Alabama, 35249, United States
Unknown Facility
Tucson, Arizona, 85741-3537, United States
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Chicago, Illinois, 60637-1470, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Vancouver, British Columbia, V6T 2B5, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Montreal, Quebec, H3A 2B4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 14, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 5, 2012
Record last verified: 2012-01