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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206635
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 22, 2012
Information provided by:

Brief Summary:
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 or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaseron, BAY86-5046)

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.

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Study Type : Observational
Actual Enrollment : 432 participants
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
Study Start Date : January 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Description of long term course of disease [ Time Frame: 16 years ]

Secondary Outcome Measures :
  1. Comparison to natural history cohort [ Time Frame: 16 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   33 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Original pivotal trial population of Betaseron pivotal study (1989-1993)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206635

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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
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Study Director: Bayer Study Director Bayer
Publications of Results:

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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. Identifier: NCT00206635    
Other Study ID Numbers: 308272
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic