Clinical trial NCT02343159: Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
Official title: A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-01-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Primary outcomes:
measure: Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
timeFrame: Month 12
Secondary outcomes:
measure: Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1
timeFrame: Month 12
measure: Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1
timeFrame: Month 6
measure: Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1
timeFrame: Month 6
measure: Persistence Rates at Months 6 and 12
timeFrame: Month 6, Month 12
measure: Compliance Rates at Month 6 and 12
timeFrame: Month 6, Month 12
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Month 6, Month 12
measure: Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
timeFrame: Month 6, Month 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Research Site
state: Alabama
city: Pheonix
country: United States
facility: Research Site
state: Arizona
city: Carlsbad
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Panorama City
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Fairfield
country: United States
facility: Research Site
state: Connecticut
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Merrillville
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Sandusky
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Bend
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Hodges
country: United States
facility: Research Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Winchester
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: