An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis

Bayer0 sites176 target enrollmentJanuary 2010

ConditionsMultiple Sclerosis

InterventionsBetaseron (Interferon beta-1b, BAY86-5046)

DrugsBetaseron (Interferon beta-1b, BAY86-5046)

Overview

Phase: Not Applicable
Intervention: Betaseron (Interferon beta-1b, BAY86-5046)
Conditions: Multiple Sclerosis
Sponsor: Bayer
Enrollment: 176
Primary Endpoint: Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include:

Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
EDSS (Expanded Disability Status Scale)
Cognition
Resource use
SPMS (Secondary Progressive Multiple Sclerosis) status
Employment history

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

December 2010

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372)
•Patient, caregiver, or legal guardian must provide written informed consent
•Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call

Exclusion Criteria

Not provided

Arms & Interventions

Group 1

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

Outcomes

Primary Outcomes

Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo)

Time Frame: 20 years