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

NCT ID: NCT00206635

Last Updated: 2012-11-22

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

432 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

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

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

Intervention Type 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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

33 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare Pharmaceuticals Inc.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, Alabama, United States

Site Status

Many Locations, Arizona, United States

Site Status

Many Locations, California, United States

Site Status

Many Locations, Illinois, United States

Site Status

Many Locations, Maryland, United States

Site Status

Many Locations, Pennsylvania, United States

Site Status

Many Locations, British Columbia, Canada

Site Status

Many Locations, Ontario, Canada

Site Status

Many Locations, Quebec, Canada

Site Status

Countries

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United Kingdom United States Canada

References

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Ebers GC, Traboulsee A, Li D, Langdon D, Reder AT, Goodin DS, Bogumil T, Beckmann K, Wolf C, Konieczny A; Investigators of the 16-year Long-Term Follow-Up Study. Analysis of clinical outcomes according to original treatment groups 16 years after the pivotal IFNB-1b trial. J Neurol Neurosurg Psychiatry. 2010 Aug;81(8):907-12. doi: 10.1136/jnnp.2009.204123. Epub 2010 Jun 19.

Reference Type RESULT
PMID: 20562430 (View on PubMed)

Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A; Investigators of the 16-Year Long-Term Follow-Up Study. Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS. Neurology. 2010 Jun 8;74(23):1877-85. doi: 10.1212/WNL.0b013e3181e240d0.

Reference Type RESULT
PMID: 20530324 (View on PubMed)

Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC; 16-Year Long Term Follow-up Study Investigators. Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon beta-1b trial in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 Mar;83(3):282-7. doi: 10.1136/jnnp-2011-301178. Epub 2011 Dec 21.

Reference Type RESULT
PMID: 22193561 (View on PubMed)

Goodin DS, Jones J, Li D, Traboulsee A, Reder AT, Beckmann K, Konieczny A, Knappertz V; 16-Year Long-Term Follow-up Study Investigators. Establishing long-term efficacy in chronic disease: use of recursive partitioning and propensity score adjustment to estimate outcome in MS. PLoS One. 2011;6(11):e22444. doi: 10.1371/journal.pone.0022444. Epub 2011 Nov 30.

Reference Type RESULT
PMID: 22140424 (View on PubMed)

Other Identifiers

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308272

Identifier Type: -

Identifier Source: org_study_id