Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: dimethyl fumarate; Medication Event Monitoring System (MEMS); Adherence counseling
Intervention description: 120 mg and 240 mg delayed release capsules; The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container; A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility 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