check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

14261

ClinicalTrials.gov Identifier:

NCT01031459

EudraCT Number:

Not Available

EU CT Number:

Not Available
Telephone interview of patients that participated in the the Pivotal Betaferon MS trial.

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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

Trial summary

Enrollment Goal
176
Trial Dates
January 2010 - December 2010
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Thomas Jefferson UniversityPhiladelphia, 19107, United States
Completed
University of Alabama at BirminghamBirmingham, 35249, United States
Completed
University of MarylandBaltimore, 21201, United States
Completed
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Completed
Hopital Neurologiques de MontrealMontreal, H3A 2B4, Canada
Completed
London Health Sciences CentreLondon, N6A 5A5, Canada
Completed
University of ChicagoChicago, 60637-1470, United States
Completed
University of California, San FranciscoSan Francisco, 94117, United States
Completed
Northwest NeuroSpecialists, PLLCTucson, 85741-3537, United States
Completed
University of British Columbia HospitalVancouver, V6T 2B5, Canada

Primary Outcome

  • 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)
    date_rangeTime Frame:
    20 years
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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