The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). 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 Type
OBSERVATIONAL
Enrollment
333
As described in the treatment arm
Annualized Relapse Rate
Time frame: 12 months
Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.
TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
Time frame: Baseline to 12 months
Change in 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.
Time frame: Baseline to 12 months
Change in Modified Fatigue Impact Scale (MFIS-5) scores.
MFIS-5 is 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.
Time frame: Baseline to 12 months
Change in Beck Depression Inventory (BDI-7) scores.
BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.
Time frame: Baseline to 12 months
Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.
The Work Productivity and Activity Impairment (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.
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Research Site
Birmingham, Alabama, United States
Research Site
Tuscon, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Jose, California, United States
Research Site
Englewood, Colorado, United States
Research Site
Dover, Delaware, United States
Research Site
Jacksonville, Florida, United States
Research Site
Lighthouse PT, Florida, United States
Research Site
Port Charlotte, Florida, United States
...and 52 more locations
Time frame: Baseline to 12 months
Change in 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.
Time frame: Baseline to 12 months
Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.
The patient-reported EDSS measures disability status based on patient report of degree of difficulty in eight different functional areas (on a 4-point scale), and overall function, taking into account the eight areas and descriptions of gait.
Time frame: Baseline to 12 months
Proportion of patients experiencing a relapse.
Time frame: Baseline to 12 months
Proportion of patients with relapses associated with hospitalizations.
Time frame: Baseline to 12 months
Proportion of patients with relapses associated with steroid use.
Time frame: Baseline to 12 months