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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

September 9, 2005
November 21, 2012
January 2005
Not Provided
Description of long term course of disease [ Time Frame: 16 years ]
Not Provided
Complete list of historical versions of study NCT00206635 on ClinicalTrials.gov Archive Site
Comparison to natural history cohort [ Time Frame: 16 years ]
Not Provided
Not Provided
Not Provided
 
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum

Non-Probability Sample

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

Multiple Sclerosis
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
Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
December 2005
Not Provided

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
Both
33 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00206635
308272
No
Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP