Trial Outcomes & Findings for Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients. (NCT NCT02343159)

Last Updated: 2017-05-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

84 participants

Primary outcome timeframe

Month 12

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	27	27	30
Overall Study COMPLETED	1	1	0
Overall Study NOT COMPLETED	26	26	30

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Early Study Termination	16	19	23
Overall Study Physician Decision	2	0	1
Overall Study Withdrawal by Subject	3	0	2
Overall Study Lost to Follow-up	0	2	2
Overall Study Adverse Event	4	4	2
Overall Study Sponsor Decision	0	1	0
Overall Study Enrollment Error	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Standard MEMS Cap n=26 Participants 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.	Arm 2: Smart MEMS Cap n=26 Participants 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.	Arm 3: Smart MEMS Cap + Counseling n=27 Participants 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.	Total n=79 Participants Total of all reporting groups
Age, Customized 18 - 50 Years	21 Participants n=93 Participants	19 Participants n=4 Participants	17 Participants n=27 Participants	57 Participants n=483 Participants
Age, Customized > 50 Years	5 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	22 Participants n=483 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	23 Participants n=4 Participants	23 Participants n=27 Participants	68 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	11 Participants n=483 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6, Month 12

Persistence rates defined as the proportion of time on treatment over the study observation time period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Standard MEMS Cap

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Arm 2: Smart MEMS Cap

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm 3: Smart MEMS Cap + Counseling

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Standard MEMS Cap n=26 participants at risk 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.	Arm 2: Smart MEMS Cap n=26 participants at risk 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.	Arm 3: Smart MEMS Cap + Counseling n=27 participants at risk 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.
Psychiatric disorders Suicide attempt	0.00% 0/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	3.8% 1/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/27 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.
Nervous system disorders Encephalopathy	0.00% 0/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	3.8% 1/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/27 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/27 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	3.8% 1/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/27 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	3.8% 1/26 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.	0.00% 0/27 • Collected between the time of informed consent and month 12 or early discontinuation visit. Safety population: Defined as all subjects who received at least one dose of study treatment.

Other adverse events

Additional Information

Biogen Study Medical Director

Biogen

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER