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

January 3, 2012 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
    • Ontario
      • London, Ontario, Canada, N6A 5A5
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
      • Montreal, Quebec, Canada, H2L 4M1
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
    • Arizona
      • Tucson, Arizona, United States, 85741-3537
    • California
      • San Francisco, California, United States, 94117
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
Telephone survey of all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14261
  • 20Y-LTF (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Betaseron (Interferon beta-1b, BAY86-5046)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe