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

Purpose

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.

Condition	Intervention
Multiple Sclerosis	Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon Beta-1b

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Description of long term course of disease [ Time Frame: 16 years ]

Secondary Outcome Measures:

Comparison to natural history cohort [ Time Frame: 16 years ]

Biospecimen Retention: Samples With DNA

Whole blood, serum

Enrollment:	432
Study Start Date:	January 2005
Study Completion Date:	December 2005

Groups/Cohorts	Assigned Interventions
Group 1	Drug: 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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	33 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Original pivotal trial population of Betaseron pivotal study (1989-1993)

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206635

Locations

United States, Alabama

Many Locations, Alabama, United States
United States, Arizona

Many Locations, Arizona, United States
United States, California

Many Locations, California, United States
United States, Illinois

Many Locations, Illinois, United States
United States, Maryland

Many Locations, Maryland, United States
United States, Pennsylvania

Many Locations, Pennsylvania, United States
Canada, British Columbia

Many Locations, British Columbia, Canada
Canada, Ontario

Many Locations, Ontario, Canada
Canada, Quebec

Many Locations, Quebec, Canada

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2010 Jun 19.

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.

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 β-1b trial in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 Mar;83(3):282-7. Epub 2011 Dec 21.

Goodin DS, Jones J, Li D, Traboulsee A, Reder AT, Beckmann K, Konieczny A, Knappertz V; and the 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. Epub 2011 Nov 30.

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00206635 History of Changes
Other Study ID Numbers:	308272
Study First Received:	September 9, 2005
Last Updated:	November 21, 2012
Health Authority:	United States: Institutional Review Board Canada: Health Canada

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta

Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 16, 2013