Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

Study Overview
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Brief Summary
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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.

Official Title
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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 Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

Conditions
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Relapsing Forms of Multiple Sclerosis

Intervention / Treatment
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* Drug: dimethyl fumarate


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations. Have the ability to read and understand written English. Have access to the internet and are able to complete online assessments on a computer Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI). Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment. Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment. Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF). Key Exclusion Criteria: Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician. 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.) Have a history of and/or current serious infections. Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed. Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA). Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry. Have received prior treatment with dimethyl fumarate (DMF). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dimethyl fumarate<br>To be taken according to the United States Prescribing Information (USPI) | Drug: dimethyl fumarate<br>* As described in the treatment arm<br>* Other names: DMF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Relapse Rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 12 months | 
| Proportion of patients experiencing a relapse. |  | Baseline to 12 months | 
| Proportion of patients with relapses associated with hospitalizations. |  | Baseline to 12 months | 
| Proportion of patients with relapses associated with steroid use. |  | Baseline to 12 months |