Multiple Sclerosis, Relapsing-RemittingIMPROVENCT02323269
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
An observational study of Multiple Sclerosis, Relapsing-Remitting and Relapsing-Remitting Multiple Sclerosis, run by Biogen at 10 sites in Canada.
Trial summary
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 10 sitesCanada
- Study dates
- May 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in male and female patients with relapsing-remitting MS who satisfy the therapeutic indication for DMF per the Canadian Product Monograph, and who are either treatment-naïve or responding suboptimally to MS platform therapies (e.g., IFN or GA), as determined by the Prescribing Physician.
Who may be able to join
- Have access to the internet and are able to complete online assessments on a computer.
- Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph.
- Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment.
Who cannot join
- Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
- Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
- Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Research Site
Burnaby, British Columbia, V5G 2X6
Research Site
Cambridge, Ontario, N1R 7L6
Research Site
Edmonton, Alberta, T6G 2G3
Research Site
Gatineau, Quebec, J9J 0A5
Research Site
Halifax, Nova Scotia, B3H 4K4
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H3A 2B4
Research Site
Saint John, New Brunswick, E2L 4L2
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Sydney, Nova Scotia, B1P 1P3
About this study
Official title: A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.
- Being tested
- dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called DMF, BG00012, Tecfidera
administered according to the local product label (i.e., Canadian Product Monograph).
| Study group | Role | What they receive |
|---|---|---|
| Treatment naive to dimethyl fumarate | Participants who are prescribed dimethyl fumarate as their initial therapy will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily. Receives: Drug: dimethyl fumarate | |
| Switch to dimethyl fumarate | Participants who are prescribed dimethyl fumarate after suboptimal response to IFN or GA will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily. Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR) at month 12
Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.
Measured: Month 12
Secondary outcomes (10)
Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score
TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
Measured: Baseline and month 12
Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
Measured: Baseline and month 12
Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores
MFIS-5 a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
Measured: Baseline and month 12
Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores
BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale.
Measured: Baseline and month 12
Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores
WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis
Measured: Baseline and month 12
Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores
MMAS-8 is a self-reporting tool to facilitate the identification of barriers to and behaviors associated with adherence to chronic medications. Scores on the MMAS-8 range from 0-8, with scores of less than 6 reflecting low adherence.
Measured: Baseline and month 12
Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores
The patient reported EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems.
Measured: Baseline and month 12
Proportion of patients relapsing at Month 12
Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.
Measured: Month 12
Proportion of patients with relapses associated with hospitalizations at Month 12
Measured: Month 12
Proportion of patients with relapses associated with steroid use at Month 12
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 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
- NCT02323269
- Sponsor's protocol ID
- 109MS415
- Other IDs
- CAN-BGT-14-10614
- Acronym
- IMPROVE
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2014
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)
- ClinicalTrials.gov ID
- NCT02323269
- Acronym / sponsor ID
- IMPROVE / 109MS415
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
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 estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment naive to dimethyl fumarate | – | Drug: dimethyl fumarateParticipants who are prescribed dimethyl fumarate as their initial therapy will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily. |
| Switch to dimethyl fumarate | – | Drug: dimethyl fumarateParticipants who are prescribed dimethyl fumarate after suboptimal response to IFN or GA will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in male and female patients with relapsing-remitting MS who satisfy the therapeutic indication for DMF per the Canadian Product Monograph, and who are either treatment-naïve or responding suboptimally to MS platform therapies (e.g., IFN or GA), as determined by the Prescribing Physician.
Key inclusion criteria (3 listed)
- Have access to the internet and are able to complete online assessments on a computer.
- Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph.
- Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment.
Key exclusion criteria (4 listed)
- Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
- Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
- Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA.
- 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: DMF, BG00012, Tecfideraadministered according to the local product label (i.e., Canadian Product Monograph). | Drug | Switch to dimethyl fumarate, Treatment naive to dimethyl fumarate |
Primary outcome
Annualized Relapse Rate (ARR) at month 12
Time frame: Month 12
Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.
10 secondary outcomes
Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score
Time frame: Baseline and month 12
Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores
Time frame: Baseline and month 12
Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores
Time frame: Baseline and month 12
Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores
Time frame: Baseline and month 12
Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores
Time frame: Baseline and month 12
Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores
Time frame: Baseline and month 12
Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores
Time frame: Baseline and month 12
Proportion of patients relapsing at Month 12
Time frame: Month 12
Proportion of patients with relapses associated with hospitalizations at Month 12
Time frame: Month 12
Proportion of patients with relapses associated with steroid use at Month 12
Time frame: Month 12
Results and safety
The study was stopped early (reason given: 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Relapsing-Remitting Multiple Sclerosis, run by Biogen at 10 sites in Canada.
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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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.
Are results available for this study?
The study was stopped early (reason given: 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.). Results are not available in the source record.
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?
Annualized Relapse Rate (ARR) at month 12 (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 8 Apr 2016.