Avonex 15 Year Long Term Follow-up Study

Multiple Sclerosis Clinical Trial

— 15yASSURANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525343
• Other study ID #: 007-06-AVX
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2007
• Last updated: March 5, 2010
• Start date: March 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Jocab's Neurological Institute	Buffalo	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Oregon Health and Science University	Portland	Oregon
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.		15 years	No