Multiple Sclerosis
Conditions
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.
Interventions
DRUGdimethyl fumarate
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
BEHAVIORALAdherence counseling
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1 | 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. |
| Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1 | 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. |
| Persistence Rates at Months 6 and 12 | Month 6, Month 12 | Persistence rates defined as the proportion of time on treatment over the study observation time period. |
| Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1 | 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. |
| Multiple Sclerosis Impact Scale (MSIS-29) | 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. |
| Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0) | 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. |
| Compliance Rates at Month 6 and 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 26 |
| 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. | 27 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 2 |
| Overall Study | Early Study Termination | 16 | 19 | 23 |
| Overall Study | Enrollment Error | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 |
| Overall Study | Physician Decision | 2 | 0 | 1 |
| Overall Study | Sponsor Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling | Total |
|---|---|---|---|---|
| Age, Customized 18 - 50 Years | 21 Participants | 19 Participants | 17 Participants | 57 Participants |
| Age, Customized > 50 Years | 5 Participants | 7 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 23 Participants | 68 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 26 | 22 / 26 | 17 / 27 |
| serious Total, serious adverse events | 1 / 26 | 1 / 26 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Compliance Rates at Month 6 and 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.
Time frame: Month 6, Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Multiple Sclerosis Impact Scale (MSIS-29)
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.
Time frame: Month 6, Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Overall Adherence Rates at Month 12: Arm 2 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.
Time frame: Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Overall Adherence Rates at Month 6: Arm 2 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.
Time frame: Month 6
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Overall Adherence Rates at Month 6: 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.
Time frame: Month 6
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Persistence Rates at Months 6 and 12
Persistence rates defined as the proportion of time on treatment over the study observation time period.
Time frame: Month 6, Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Secondary
Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
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.
Time frame: Month 6, Month 12
Population: The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.