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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.
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:
Secondary endpoints were:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life. | 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Foulds, MD | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Jocab's Neurological Institute |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Buffalo |
| New York |
| 14203 |
| United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |