Multiple Sclerosis
Conditions
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.
Interventions
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
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
33 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of long term course of disease | 16 years |
Secondary
| Measure | Time frame |
|---|---|
| Comparison to natural history cohort | 16 years |
Countries
Canada, United States
Outcome results
None listed