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

Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031459
• Other study ID #: 14261
• Secondary ID: 20Y-LTF
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: January 3, 2012
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Betaseron (Interferon beta-1b, BAY86-5046)
Telephone survey of all patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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