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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Telephone survey of all patients.

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Dec 14, 2009
Registry last updated: Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed