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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00525343
First received: September 4, 2007
Last updated: March 5, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Phase
Multiple Sclerosis
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

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

Secondary Outcome Measures:
  • To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life. [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: March 2007
Study Completion Date: September 2008
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525343

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, New York
Jocab's Neurological Institute
Buffalo, New York, United States, 14203
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Pamela Foulds, MD Biogen Idec
  More Information

No publications provided

Responsible Party: Pamula Foulds, Biogen Idec
ClinicalTrials.gov Identifier: NCT00525343     History of Changes
Other Study ID Numbers: 007-06-AVX
Study First Received: September 4, 2007
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
Avonex pivotal trial
Avonex
Avonex long term follow-up
Avonex outcomes

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013