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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00206635
First received: September 9, 2005
Last updated: November 21, 2012
Last verified: November 2012
  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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014