Trial Condition(s):

Multiple Sclerosis

Telephone interview of patients that participated in the the Pivotal Betaferon MS trial.

Bayer Identifier:

14261

ClinicalTrials.gov Identifier:

NCT01031459

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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:
1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
2. EDSS (Expanded Disability Status Scale)
3. Cognition
4. Resource use
5. SPMS (Secondary Progressive Multiple Sclerosis) status
6. Employment history

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
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
176
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Thomas Jefferson University

Philadelphia, United States, 19107

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham , United States, 35249

Status
Completed
 
Locations

University of Maryland

Baltimore , United States, 21201

Status
Completed
 
Locations

CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

Status
Completed
 
Locations

Hopital Neurologiques de Montreal

Montreal, Canada, H3A 2B4

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

University of Chicago

Chicago, United States, 60637-1470

Status
Completed
 
Locations

University of California, San Francisco

San Francisco, United States, 94117

Status
Completed
 
Locations

Northwest NeuroSpecialists, PLLC

Tucson, United States, 85741-3537

Status
Completed
 
Locations

University of British Columbia Hospital

Vancouver, Canada, V6T 2B5

Status
Completed
 

Trial Design