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

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02343159
• Other study ID #: 109MS413
• Status: Terminated
• Phase: Phase 4
• First received: January 9, 2015
• Last updated: August 24, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to determine whether a MEMS® cap with a LCD reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in MS patients as compared to a MEMS (Medication Event Monitoring System) cap without a 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 a LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without a 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 LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without a 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
120 mg and 240 mg delayed release capsules

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

Locations

Country	Name	City	State
United States	Research Site	Akron	Ohio
United States	Research Site	Auburn	Minnesota
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Fairfield	Connecticut
United States	Research Site	Gainesville	Florida
United States	Research Site	Hodges	South Carolina
United States	Research Site	Homewood	Alabama
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Merrillville	Indiana
United States	Research Site	Oceanside	California
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Panorama City	California
United States	Research Site	Pheonix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Round Rock	Texas
United States	Research Site	Sandusky	Ohio
United States	Research Site	Tampa	Florida
United States	Research Site	Vero Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of adherence overall rates between Arm 3 and 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	Up to 12 months	No
Secondary	Comparison of overall adherence rates between Arm 2 and Arm 1		Up to 12 months	No
Secondary	Comparison of overall adherence rates between Arm 3 and Arm 1, and between Arm 2 and Arm 1		Up to 6 months	No
Secondary	Proportion of time on treatment (persistence rates) by study arms		Up to 12 months	No
Secondary	Proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during a treatment period (compliance rates) by study arms		Up to 12 months	No
Secondary	Patient Reported Outcome (PRO) measurements for Multiple Sclerosis Impact Scale (MSIS-29 score)	The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's 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.	Up to 12 months	No
Secondary	Patient Reported Outcome (PRO) measurements for Work Productivity and Activity Impairment Questionnaire (WPAI: MS v2.0 score)	The Work Productivity and Activity Impairment (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.	Up to 12 months	No