Multiple SclerosisPhase 4NCT02343159
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
A Phase 4 study testing dimethyl fumarate, Medication Event Monitoring System (MEMS) and Adherence counseling in people with Multiple Sclerosis, run by Biogen at 29 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dimethyl fumarate, Medication Event Monitoring System (MEMS) and Adherence counseling
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 29 sitesUnited States
- Study dates
- 28 Feb 2015to 15 Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Research Site
Akron, Ohio, 44320
Research Site
Auburn, Maine, 04210
Research Site
Aurora, Colorado, 80045
Research Site
Bend, Oregon, 97701
Research Site
Boston, Massachusetts, 02135
Research Site
Carlsbad, California, 92011
Research Site
Colorado Springs, Colorado, 80907
Research Site
Columbus, Ohio, 43221
Research Site
Fairfield, Connecticut, 06824
Research Site
Gainesville, Florida, 32607
Research Site
Hodges, South Carolina, 29653-9181
Research Site
Homewood, Alabama, 35209
Research Site
Lexington, Kentucky, 40513
Research Site
Los Angeles, California, 90095
Research Site
Merrillville, Indiana, 46410
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Ormond Beach, Florida, 32174
Research Site
Panorama City, California, 91402
Research Site
Pheonix, Arizona, 85018
Research Site
Portland, Oregon, 97225
Research Site
Round Rock, Texas, 78681
Research Site
Sacramento, California, 95816
Research Site
Sandusky, Ohio, 44870
Research Site
St Louis, Missouri, 63141
Research Site
Tampa, Florida, 33612
Research Site
Toledo, Ohio, 43623
Research Site
Vero Beach, Florida, 32960
Research Site
Wichita, Kansas, 67214
Research Site
Winchester, Virginia, 22601
About this study
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.
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.
- Conditions
- Multiple Sclerosis
- Being tested
- dimethyl fumarate, Medication Event Monitoring System (MEMS), Adherence counseling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called Tecfidera, DMF, BG000012
120 mg and 240 mg delayed release capsules
Medication Event Monitoring System (MEMS)Device
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Adherence counselingBehavioural
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard MEMS Cap | Experimental | 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. Receives: Drug: dimethyl fumarate; Device: Medication Event Monitoring System (MEMS) |
| Arm 2: Smart MEMS Cap | Experimental | 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. Receives: Drug: dimethyl fumarate; Device: Medication Event Monitoring System (MEMS) |
| Arm 3: Smart MEMS Cap + Counseling | Experimental | 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. Receives: Drug: dimethyl fumarate; Device: Medication Event Monitoring System (MEMS); Behavioral: Adherence counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (7)
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.
Measured: Month 12
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.
Measured: Month 6
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.
Measured: Month 6
Persistence Rates at Months 6 and 12
Persistence rates defined as the proportion of time on treatment over the study observation time period.
Measured: Month 6, Month 12
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.
Measured: Month 6, Month 12
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.
Measured: Month 6, Month 12
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.
Measured: Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start28 Feb 2015
- Primary completion15 Apr 2016
- Study completion15 Apr 2016
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343159
- Sponsor's protocol ID
- 109MS413
- Status last verified
- Apr 2017
- First submitted
- 9 Jan 2015
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02343159
- Acronym / sponsor ID
- 109MS413
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 84 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2015 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard MEMS Cap | Experimental | Drug: dimethyl fumarate, Device: Medication Event Monitoring System (MEMS)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 | Experimental | Drug: dimethyl fumarate, Device: Medication Event Monitoring System (MEMS)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 | Experimental | Drug: dimethyl fumarate, Device: Medication Event Monitoring System (MEMS), Behavioral: Adherence counselingA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimethyl fumarateAlso: Tecfidera, DMF, BG000012120 mg and 240 mg delayed release capsules | Drug | Arm 1: Standard MEMS Cap, Arm 2: Smart MEMS Cap, Arm 3: Smart MEMS Cap + Counseling |
| 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 | Device | Arm 1: Standard MEMS Cap, Arm 2: Smart MEMS Cap, Arm 3: Smart MEMS Cap + Counseling |
| Adherence counselingA telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader) | Behavioural | Arm 3: Smart MEMS Cap + Counseling |
Primary outcome
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
Time frame: 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.
7 secondary outcomes
Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1
Time frame: Month 12
Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1
Time frame: Month 6
Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1
Time frame: Month 6
Persistence Rates at Months 6 and 12
Time frame: Month 6, Month 12
Compliance Rates at Month 6 and 12
Time frame: Month 6, Month 12
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Month 6, Month 12
Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
Time frame: Month 6, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dimethyl fumarate, Medication Event Monitoring System (MEMS) and Adherence counseling in people with Multiple Sclerosis, run by Biogen at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1 (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.