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

N/ACompletedNCT00206635

Bayer432 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

432

Conditions

Multiple Sclerosis

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

Eligibility

Sex: ALLMin age: 33 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Many Locations, Alabama, United States

Unnamed facility

Many Locations, Arizona, United States

Unnamed facility

Many Locations, California, United States

Unnamed facility

Many Locations, Illinois, United States

Outcomes

Primary Outcomes

Description of long term course of disease

Time frame: 16 years

Secondary Outcomes

Comparison to natural history cohort

Time frame: 16 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.