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

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ClinicalTrials.gov Identifier: NCT02343159
Recruitment Status : Terminated (Sponsor Decision)
First Posted : January 21, 2015
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: dimethyl fumarate Device: Medication Event Monitoring System (MEMS) Behavioral: Adherence counseling Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
Actual Study Start Date : February 28, 2015
Actual Primary Completion Date : April 15, 2016
Actual Study Completion Date : April 15, 2016

Resource links provided by the National Library of Medicine


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:
  • Tecfidera
  • DMF
  • 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:
  • Tecfidera
  • DMF
  • 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:
  • Tecfidera
  • DMF
  • 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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343159


Locations
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United States, Alabama
Research Site
Homewood, Alabama, United States, 35209
United States, Arizona
Research Site
Pheonix, Arizona, United States, 85018
United States, California
Research Site
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
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
Research Site
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Research Site
Fairfield, Connecticut, United States, 06824
United States, Florida
Research Site
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
United States, Indiana
Research Site
Merrillville, Indiana, United States, 46410
United States, Kansas
Research Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40513
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02135
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63141
United States, Ohio
Research Site
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
United States, Oregon
Research Site
Bend, Oregon, United States, 97701
Research Site
Portland, Oregon, United States, 97225
United States, South Carolina
Research Site
Hodges, South Carolina, United States, 29653-9181
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Site
Round Rock, Texas, United States, 78681
United States, Virginia
Research Site
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02343159    
Other Study ID Numbers: 109MS413
First Posted: January 21, 2015    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs