Avonex 15 Year Long Term Follow-up Study — 15yASSURANCE  

Multiple Sclerosis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00525343
• Study type: Observational
• Source: Biogen
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Completion date: September 2008