Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01031459
First received: December 8, 2009
Last updated: January 3, 2012
Last verified: January 2012
  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

Condition Intervention
Multiple Sclerosis
Drug: Betaseron (Interferon beta-1b, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 176
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Betaseron (Interferon beta-1b, BAY86-5046)
Telephone survey of all patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with MS that participated in the 16Y-LTF and Pivitol studies

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031459

Locations
United States, Alabama
Birmingham, Alabama, United States, 35249
United States, Arizona
Tucson, Arizona, United States, 85741-3537
United States, California
San Francisco, California, United States, 94117
United States, Illinois
Chicago, Illinois, United States, 60637-1470
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Canada, British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Phamaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01031459     History of Changes
Other Study ID Numbers: 14261, 20Y-LTF
Study First Received: December 8, 2009
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferons
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on October 19, 2014