Avonex 15 Year Long Term Follow-up Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00525343

Acronym

15yASSURANCE

Enrollment

122

Registered

2007-09-05

Start date

2007-03-31

Completion date

2008-09-30

Last updated

2010-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Avonex pivotal trial, Avonex, Avonex long term follow-up, Avonex outcomes

Brief summary

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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.	15 years

Secondary

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

Countries

United States

Outcome results