NCT00206635

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Shorter than P25 for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

First QC Date

September 9, 2005

Last Update Submit

November 21, 2012

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Description of long term course of disease

    16 years

Secondary Outcomes (1)

  • Comparison to natural history cohort

    16 years

Study Arms (1)

Group 1

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

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)DRUG

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

Group 1

Eligibility Criteria

Age33 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Many Locations, Alabama, United States

Location

Unknown Facility

Many Locations, Arizona, United States

Location

Unknown Facility

Many Locations, California, United States

Location

Unknown Facility

Many Locations, Illinois, United States

Location

Unknown Facility

Many Locations, Maryland, United States

Location

Unknown Facility

Many Locations, Pennsylvania, United States

Location

Unknown Facility

Many Locations, British Columbia, Canada

Location

Unknown Facility

Many Locations, Ontario, Canada

Location

Unknown Facility

Many Locations, Quebec, Canada

Location

Related Publications (4)

  • 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.

    PMID: 20562430RESULT

  • 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.

    PMID: 20530324RESULT

  • 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.

    PMID: 22193561RESULT

  • 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.

    PMID: 22140424RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 21, 2005

Study Start

January 1, 2005

Study Completion

December 1, 2005

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

US(6)CA(3)