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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00819000 |
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.
Condition | Intervention |
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Multiple Sclerosis |
Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcu), and IFN-beta 1b |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies |
Estimated Enrollment: | 3000 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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
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Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcu), and IFN-beta 1b
MS therapies (listed above) used according to prescribers' instructions.
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Specialty Pharmacies are a common source of drug supply for patients with MS. In addition to promoting and maintaining medication compliance and adherence to MS therapies, a few Specialty Pharmacies are taking their collaboration with health care providers further. They are managing the MS patients' adverse effects of medication, offering self-management tools and providing ongoing education to MS patients as well as assessing possible suboptimal medication response and notifying the health care providers about issues the patients are experiencing between their office visits. This study is being conducted in collaboration with Specialty Pharmacies that offer the full spectrum of patient services to those receiving glatiramer acetate and the beta interferons. It will examine the impact of various therapy compliance and adherence levels as well as other disease management factors that may influence patient health outcomes in MS over a two year period.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
(3) Walgreen Co. and its specialty pharmacy subsidiaries and affiliates, | Not yet recruiting |
Deerfield, Illinois, United States, 60015 | |
United States, Michigan | |
Diplomat Specialty Pharmacy | Recruiting |
Swartz Creek, Michigan, United States, 48473 | |
Contact: Cora L Edwards, BA, CCRP 810-720-6851 cedwards@diplomatpharmacy.com | |
United States, Ohio | |
BioScrip, Inc. | Not yet recruiting |
Columbus, Ohio, United States, 43228 | |
Contact: Kira Botkin, BA 614-850-1230 kbotkin@bioscrip.com |
Study Chair: | MerriKay Oleen-Burkey, PhD | Teva Neuroscience, Inc. |
Study Director: | Howard Zwibel, MD | Neurologic Center of South Florida |
Responsible Party: | Teva Neuroscience ( MerriKay Oleen-Burkey, PhD. Director, Outcomes Research ) |
Study ID Numbers: | PM032 |
Study First Received: | January 7, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00819000 History of Changes |
Health Authority: | United States: Institutional Review Board |
Specialty Pharmacy Therapy Management Medication Compliance |
Medication Adherence Medication Persistence Health Outcomes |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Interferons Adjuvants, Immunologic Interferon-beta Sclerosis Immunosuppressive Agents |
Antiviral Agents Copolymer 1 Multiple Sclerosis Interferon beta 1a Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Interferon-beta |
Sclerosis Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |