Avonex 15 Year Long Term Follow-up Study (15yASSURANCE)

March 5, 2010 updated by: Biogen

Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs

The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study, evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative Research Group (MSCRG) study.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of MS measured by the self-reported EDSS.

Primary endpoints for this study were as follows:

  1. Changes in EDSS score from baseline for original Avonex® pivotal trial
  2. Percentage of patients with EDSS scores less than or equal to 4
  3. Percentage of patients with EDSS scores less than or equal to 6
  4. Percentage of patients with EDSS scores less than or equal to 7

Secondary endpoints were:

  1. Percentage of patients alive
  2. Percentage of patients living independently
  3. SF 36 Quality of Life status
  4. Self-reported VAS of independence with self-care

Study Type

Observational

Enrollment (Actual)

122

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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • Jocab's Neurological Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.

Description

Inclusion Criteria:

  1. Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
  2. Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
  3. Signed written informed consent form

Exclusion Criteria:

  1. Unwillingness or inability to comply with the requirements of this protocol.
  2. Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the impact of early versus delayed initiation of treatment on the long-term disability status of patients with relapsing forms of multiple sclerosis (MS) measured by the self-reported EDSS.
Time Frame: 15 years
15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.
Time Frame: 15 years
15 years

Collaborators and Investigators

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

Sponsor

Biogen

Investigators

  • Study Director: Pamela Foulds, MD, Biogen

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

March 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

March 8, 2010

Last Update Submitted That Met QC Criteria

March 5, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007-06-AVX

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.

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