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)
- Conditions
- Multiple Sclerosis, Relapsing-RemittingRelapsing-Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT02323269
- Lead Sponsor
- Biogen
- Brief 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 (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment naive to dimethyl fumarate 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. Switch to dimethyl fumarate 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.
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate (ARR) at month 12 Month 12 Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.
- Secondary Outcome Measures
Name Time Method Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores Baseline and month 12 WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis
Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores Baseline and month 12 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.
Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score Baseline and month 12 TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores Baseline and month 12 BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale.
Proportion of patients relapsing at Month 12 Month 12 Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.
Proportion of patients with relapses associated with hospitalizations at Month 12 Month 12 Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores Baseline and month 12 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.
Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores Baseline and month 12 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.
Proportion of patients with relapses associated with steroid use at Month 12 Month 12 Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores Baseline and month 12 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.
Trial Locations
- Locations (1)
Research Site
🇨🇦Montreal, Quebec, Canada