Avonex 15 Year Long Term Follow-up Study

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgetown University Medical Center, Washington D.C., District of Columbia, United States

About this study

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:

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

Secondary endpoints were:

Percentage of patients alive
Percentage of patients living independently
SF 36 Quality of Life status
Self-reported VAS of independence with self-care

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.

Time frame: 15 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: 15yASSURANCE

Important dates

Study start: 2007
Study completion: 2008
First posted: Sep 5, 2007
Registry last updated: Mar 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed