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

Bayer176 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Multiple Sclerosis

Interventions

Betaseron (Interferon beta-1b, BAY86-5046)DRUG

Telephone survey of all patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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