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The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated MS Subjects | Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b | Drug | MS therapies (listed above) used according to prescribers' instructions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes | 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes | 12 months and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
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| Name | Affiliation | Role |
|---|---|---|
| MerriKay Oleen-Burkey, PhD | Teva Neuroscience, Inc. | Study Chair |
| Howard Zwibel, MD | Neurologic Center of South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site | Swartz Creek | Michigan | United States | |||
| Teva Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25787057 | Derived | Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H. Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse. Mult Scler Relat Disord. 2015 Jan;4(1):75-82. doi: 10.1016/j.msard.2014.09.214. Epub 2014 Oct 7. | |
| 24624979 | Derived | Coyle PK, Cohen BA, Leist T, Markowitz C, Oleen-Burkey M, Schwartz M, Tullman MJ, Zwibel H. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes. BMC Neurol. 2014 Mar 13;14:49. doi: 10.1186/1471-2377-14-49. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D055118 | Medication Adherence |
| 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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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D007279 | Injections, Subcutaneous |
| D000068556 | Interferon beta-1a |
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
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|
| Columbus |
| Ohio |
| United States |
| Teva Investigational Site | Carnegie | Pennsylvania | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004358 |
| Drug Therapy |
| D013812 | Therapeutics |
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |