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Study 19 of 2431 for search of: | received on or after 11/14/2008 |
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Descriptive Information Fields | |||||||||
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Brief Title † | Therapy Optimization in Multiple Sclerosis (MS) | ||||||||
Official Title † | TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies | ||||||||
Brief Summary | 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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Detailed Description | 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. |
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Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | Cohort, Prospective | ||||||||
Primary Outcome Measure † | Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ] | ||||||||
Secondary Outcome Measure † | Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ] | ||||||||
Condition † | Multiple Sclerosis | ||||||||
Intervention † | Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcu), and IFN-beta 1b | ||||||||
MEDLINE PMIDs | |||||||||
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Recruitment Information Fields | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 3000 | ||||||||
Start Date † | December 2008 | ||||||||
Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Administrative Information Fields | |||||||||
NCT ID † | NCT00819000 | ||||||||
Organization ID | PM032 | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Teva Pharmaceutical Industries | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Teva Pharmaceutical Industries | ||||||||
Verification Date | January 2009 | ||||||||
First Received Date † | January 7, 2009 | ||||||||
Last Updated Date | January 7, 2009 |