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

Bayer

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00206635

308272

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 patients

Sex: All

Ages: 33+ years old

Volunteers: No Healthy Volunteers

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

Trial design

432 participants in 1 patient group

Group 1

Treatment:

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