Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

April 11, 2017 updated by: Biogen

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Research Site
    • Arizona
      • Pheonix, Arizona, United States, 85018
        • Research Site
    • California
      • Carlsbad, California, United States, 92011
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Panorama City, California, United States, 91402
        • Research Site
      • Sacramento, California, United States, 95816
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
      • Vero Beach, Florida, United States, 32960
        • Research Site
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44320
        • Research Site
      • Columbus, Ohio, United States, 43221
        • Research Site
      • Sandusky, Ohio, United States, 44870
        • Research Site
      • Toledo, Ohio, United States, 43623
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
      • Portland, Oregon, United States, 97225
        • Research Site
    • South Carolina
      • Hodges, South Carolina, United States, 29653-9181
        • Research Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Research Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • Research Site
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Standard MEMS Cap
A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
Drug: dimethyl fumarate
120 mg and 240 mg delayed release capsules
Other Names:
  • DMF
  • Tecfidera
  • BG000012
Device: Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Experimental: Arm 2: Smart MEMS Cap
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
Drug: dimethyl fumarate
120 mg and 240 mg delayed release capsules
Other Names:
  • DMF
  • Tecfidera
  • BG000012
Device: Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Experimental: Arm 3: Smart MEMS Cap + Counseling
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
Drug: dimethyl fumarate
120 mg and 240 mg delayed release capsules
Other Names:
  • DMF
  • Tecfidera
  • BG000012
Device: Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Behavioral: Adherence counseling
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
Time Frame: Month 12
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1
Time Frame: Month 12
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Month 12
Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1
Time Frame: Month 6
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Month 6
Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1
Time Frame: Month 6
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Month 6
Persistence Rates at Months 6 and 12
Time Frame: Month 6, Month 12
Persistence rates defined as the proportion of time on treatment over the study observation time period.
Month 6, Month 12
Compliance Rates at Month 6 and 12
Time Frame: Month 6, Month 12
Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.
Month 6, Month 12
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: Month 6, Month 12
The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
Month 6, Month 12
Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
Time Frame: Month 6, Month 12
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2015

Primary Completion (Actual)

April 15, 2016

Study Completion (Actual)

April 15, 2016

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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