Multiple Sclerosis Clinical Trial
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
Summary
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD reader (a "standard" cap) and no patient counseling intervention (standard of care, Arm 1) at Month 12.
The secondary objectives of this study in this study population are: to determine if data display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the addition of patient counseling intervention based on MEMS data (Arm 3), or data display from a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.
Eligibility Criteria
Key Inclusion Criteria:
The candidate is a DMF-naïve patient
Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic indication for DMF
Have a recent (i.e., within the previous 6 months) complete blood count with results that do not preclude the patient's participation in the study, in the judgment of the Investigator
Key Exclusion Criteria:
Have comorbid conditions that preclude participation in the study, as determined by the Investigator
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
Are participating, planning to participate, or have participated in the Tecfidera QuickStart Program
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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There are 29 Locations for this study
Homewood Alabama, 35209, United States
Pheonix Arizona, 85018, United States
Carlsbad California, 92011, United States
Los Angeles California, 90095, United States
Panorama City California, 91402, United States
Sacramento California, 95816, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80907, United States
Fairfield Connecticut, 06824, United States
Gainesville Florida, 32607, United States
Ormond Beach Florida, 32174, United States
Tampa Florida, 33612, United States
Vero Beach Florida, 32960, United States
Merrillville Indiana, 46410, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40513, United States
Auburn Maine, 04210, United States
Boston Massachusetts, 02135, United States
St. Louis Missouri, 63141, United States
Akron Ohio, 44320, United States
Columbus Ohio, 43221, United States
Sandusky Ohio, 44870, United States
Toledo Ohio, 43623, United States
Bend Oregon, 97701, United States
Portland Oregon, 97225, United States
Hodges South Carolina, 29653, United States
Mt. Pleasant South Carolina, 29464, United States
Round Rock Texas, 78681, United States
Winchester Virginia, 22601, United States
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