Clinical trial NCT02323269: 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)
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Key Inclusion Criteria:

* 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:

* 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.

Primary outcomes:
measure: Annualized Relapse Rate (ARR) at month 12
timeFrame: Month 12
Secondary outcomes:
measure: Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores
timeFrame: Baseline and month 12
measure: Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores
timeFrame: Baseline and month 12
measure: Proportion of patients relapsing at Month 12
timeFrame: Month 12
measure: Proportion of patients with relapses associated with hospitalizations at Month 12
timeFrame: Month 12
measure: Proportion of patients with relapses associated with steroid use at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Burnaby
country: Canada
facility: Research Site
state: British Columbia
city: St. John
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Research Site
state: Nova Scotia
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: