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

Completed

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT01031459

Run by

Bayer

People needed

176

Starts

2010-01-01

Expected to finish

2010-12-01

Last updated by the study team

2012-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — San Francisco, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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