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CompletedNCT00206635Updated Nov 22, 2012

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

An observational study in Multiple Sclerosis, sponsored by Bayer. Completed at 9 sites in 2 countries. Open to participants aged 33 Years and older. Per ClinicalTrials.gov, last updated 2012-11-22.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
432
Ages
33 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 432 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
33 Years and older
Sexes eligible
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

Exclusion Criteria:

  • North American patients cannot be included if they have not participated in the original Betaseron trial from 1988-1993
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
432 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1

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

Interventions

  • DrugInterferon 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

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What researchers measure

Primary outcomes

  1. Description of long term course of disease

    Time frame: 16 years

Secondary outcomes

  1. Comparison to natural history cohort

    Time frame: 16 years

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Study locations

9 sites
  • Many Locations, Alabama, United States
  • Many Locations, Arizona, United States
  • Many Locations, California, United States
  • Many Locations, Illinois, United States
  • Many Locations, Maryland, United States
  • Many Locations, Pennsylvania, United States
  • Many Locations, British Columbia, Canada
  • Many Locations, Ontario, Canada
  • Many Locations, Quebec, Canada
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References and documents

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. PubMed 20562430 ↗
  • 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. PubMed 20530324 ↗
  • 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. PubMed 22193561 ↗
  • 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. PubMed 22140424 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00206635
Lead sponsor
Bayer
First posted
Sep 21, 2005
Start date
Jan 2005
Completion
Dec 2005
Last update
Nov 22, 2012

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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