Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01031459
• Date of registration: 08/12/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
• Scientific title: 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
• Date of first enrolment: January 2010
• Target sample size: 176
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01031459
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

Canada, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Betaseron (Interferon beta-1b, BAY86-5046)

Primary Outcome(s)

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) [Time Frame: 20 years]

Secondary ID(s)

14261

20Y-LTF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors