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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT00206635
• Lead Sponsor: Bayer

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.

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2005-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Description of long term course of disease	16 years

Secondary Outcome Measures

Name	Time	Method
Comparison to natural history cohort	16 years