- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206635
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
November 21, 2012 updated by: Bayer
A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
432
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Many Locations, British Columbia, Canada
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Ontario
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Many Locations, Ontario, Canada
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Quebec
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Many Locations, Quebec, Canada
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Alabama
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Many Locations, Alabama, United States
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Arizona
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Many Locations, Arizona, United States
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California
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Many Locations, California, United States
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Illinois
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Many Locations, Illinois, United States
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Maryland
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Many Locations, Maryland, United States
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Pennsylvania
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Many Locations, Pennsylvania, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Original pivotal trial population of Betaseron pivotal study (1989-1993)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Description of long term course of disease
Time Frame: 16 years
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16 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Comparison to natural history cohort
Time Frame: 16 years
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16 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1136/jnnp.2009.204123. 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. doi: 10.1212/WNL.0b013e3181e240d0.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
November 22, 2012
Last Update Submitted That Met QC Criteria
November 21, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-beta
- Interferon beta-1b
Other Study ID Numbers
- 308272
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
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