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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

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

Intervention Type DRUG

Telephone survey of all patients.

Interventions

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

Telephone survey of all patients.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No