Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis

The purpose of this follow-up study is to look carefully at the long-term course of multiple sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were previously enrolled in the original North American study that led to the marketing approval of Betaseron.

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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

33 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, British Columbia, Canada

About this study

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients in North America have to have been previously enrolled in the original Betaseron trial from 1988-1993
Be able to understand the consent form (or have a guardian who can)

Exclusion criteria

North American patients cannot be included if they have not participated in the original Betaseron trial from 1988-1993

Treatment and study plan

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

Drug

Betaseron was not administered as part of this study, only the treatment and disease status was assessed. As part of the MRI analysis Gadolinium was administered in patients who underwent this procedure

Primary outcomes

Description of long term course of disease

Time frame: 16 years

Secondary outcomes

Comparison to natural history cohort

Time frame: 16 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis

Important dates

Study start: 2005
Study completion: 2005
First posted: Sep 21, 2005
Registry last updated: Nov 22, 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