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

Biogen

Status and phase: Terminated; Phase 4

Conditions: Multiple Sclerosis

Treatments: Device: Medication Event Monitoring System (MEMS); Drug: dimethyl fumarate; Behavioral: Adherence counseling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343159

109MS413

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Arm 1: Standard MEMS Cap

Experimental group

Description:

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.

Treatment:

Device: Medication Event Monitoring System (MEMS)

Drug: dimethyl fumarate

Arm 2: Smart MEMS Cap

Experimental group

Description:

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.

Treatment:

Device: Medication Event Monitoring System (MEMS)

Drug: dimethyl fumarate

Arm 3: Smart MEMS Cap + Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Adherence counseling

Device: Medication Event Monitoring System (MEMS)

Drug: dimethyl fumarate