Avonex 15 Year Long Term Follow-up Study

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT00525343
• Lead Sponsor: Biogen

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

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Study Completion: 2008-09
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-05
• Last Update Posted: 2010-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (4)

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Jocab's Neurological Institute; 🇺🇸 Buffalo, New York, United States