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

NCT02343159 | Terminated Phase 4 Results DMC

• 1 other identifier: 109MS413
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 29

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1

  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 Outcomes (7)

• Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1

  Month 12

• Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1

  Month 6

• Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1

  Month 6

• Persistence Rates at Months 6 and 12

  Month 6, Month 12

• Compliance Rates at Month 6 and 12

  Month 6, Month 12

Study Arms (3)

Arm 1: Standard MEMS Cap

EXPERIMENTAL

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; Device: Medication Event Monitoring System (MEMS)

Arm 2: Smart MEMS Cap

EXPERIMENTAL

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; Device: Medication Event Monitoring System (MEMS)

Arm 3: Smart MEMS Cap + Counseling

EXPERIMENTAL

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; Device: Medication Event Monitoring System (MEMS); Behavioral: Adherence counseling

Interventions

dimethyl fumarate DRUG

120 mg and 240 mg delayed release capsules

Also known as: Tecfidera, DMF, BG000012

Arm 1: Standard MEMS Cap; Arm 2: Smart MEMS Cap; Arm 3: Smart MEMS Cap + Counseling

Medication Event Monitoring System (MEMS) DEVICE

The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container

Arm 1: Standard MEMS Cap; Arm 2: Smart MEMS Cap; Arm 3: Smart MEMS Cap + Counseling

Adherence counseling BEHAVIORAL

A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)

Arm 3: Smart MEMS Cap + Counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (29)

Research Site

Homewood, Alabama, 35209, United States

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Pheonix, Arizona, 85018, United States

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Carlsbad, California, 92011, United States

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Los Angeles, California, 90095, United States

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Panorama City, California, 91402, United States

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Sacramento, California, 95816, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80907, United States

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Fairfield, Connecticut, 06824, United States

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Gainesville, Florida, 32607, United States

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Ormond Beach, Florida, 32174, United States

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Tampa, Florida, 33612, United States

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Vero Beach, Florida, 32960, United States

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Merrillville, Indiana, 46410, United States

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Wichita, Kansas, 67214, United States

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Lexington, Kentucky, 40513, United States

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Auburn, Maine, 04210, United States

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Boston, Massachusetts, 02135, United States

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St Louis, Missouri, 63141, United States

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Akron, Ohio, 44320, United States

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Columbus, Ohio, 43221, United States

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Sandusky, Ohio, 44870, United States

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Toledo, Ohio, 43623, United States

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Bend, Oregon, 97701, United States

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Portland, Oregon, 97225, United States

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Hodges, South Carolina, 29653-9181, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Round Rock, Texas, 78681, United States

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Winchester, Virginia, 22601, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 21, 2015
• Study Start: February 28, 2015
• Primary Completion: April 15, 2016
• Study Completion: April 15, 2016
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (29)