NCT00525343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 8, 2010

Status Verified

March 1, 2010

First QC Date

September 4, 2007

Last Update Submit

March 5, 2010

Conditions

Multiple Sclerosis

Keywords

Avonex pivotal trialAvonexAvonex long term follow-upAvonex outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.

    15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.

You may qualify if:

  • Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
  • Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
  • Signed written informed consent form

You may not qualify if:

  • Unwillingness or inability to comply with the requirements of this protocol.
  • Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Jocab's Neurological Institute

Buffalo, New York, 14203, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pamela Foulds, MD

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

March 1, 2007

Study Completion

September 1, 2008

Last Updated

March 8, 2010

Record last verified: 2010-03

Locations

US(4)