Clinical trial NCT00525343: Avonex 15 Year Long Term Follow-up Study
Official title: Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Avonex pivotal trial
Avonex
Avonex long term follow-up
Avonex outcomes
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 15 years
Secondary outcomes:
measure: To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.
timeFrame: 15 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Buffalo
country: United States
facility: Jocab's Neurological Institute
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Biogen
name: Pamela Foulds, MD
role: STUDY_DIRECTOR
References: