Therapy Optimization in Multiple Sclerosis (MS)
Information source: Teva Pharmaceutical Industries
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Teva Neuroscience, Inc. Official(s) and/or principal investigator(s):
MerriKay Oleen-Burkey, PhD, Study Chair, Affiliation: Teva Neuroscience, Inc.
Howard Zwibel, MD, Study Director, Affiliation: Neurologic Center of South Florida
Overall contact:
Please provide NCT# SharedSolutions, Phone: 800-887-8100
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.
Clinical Details
Official title: TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes
Secondary outcome: Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, 18 years of age or older, with a diagnosis of MS.
- Being treated with Glatiramer Acetate (GA) or (IFN)-β
- Receiving therapy from a participating Specialty Pharmacy
Exclusion Criteria:
- Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to
become pregnant, or breast feeding during the study
- Has received an experimental drug in the last thirty (30) days other than Fampridine
SR (4-aminopyridine or 4-AP)
- Unlikely to be able to participate for the full two years of the study
Locations and Contacts
Please provide NCT# SharedSolutions, Phone: 800-887-8100
Teva Investigational Site, Swartz Creek, Michigan, United States; Active, not recruiting
Teva Investigational Site, Columbus, Ohio, United States; Recruiting
Shared Solutions, Phone: 800-887-8100
Teva Investigational Site, Carnegie, Pennsylvania, United States; Recruiting
Shared Solutions, Phone: 800-887-8100
Additional Information
Starting date: December 2008
Last updated: August 4, 2010
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