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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate | To be taken according to the United States Prescribing Information (USPI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | As described in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate | 12 months |
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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This study will be conducted in male and female patients with relapsing forms of MS who satisfy the therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information, and who are suboptimal responders to glatiramer acetate (GA), as determined by the Prescribing Physician.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33225410 | Derived | Repovic P, Robertson D, Kresa-Reahl K, Cohan SL, Su R, Avila R, Koulinska I, Mendoza JP. Effectiveness of Dimethyl Fumarate in Patients With Relapsing Multiple Sclerosis Switching After Suboptimal Response to Glatiramer Acetate, Including Patients With Early Multiple Sclerosis: Subgroup Analysis of RESPOND. Neurol Ther. 2021 Jun;10(1):169-182. doi: 10.1007/s40120-020-00223-2. Epub 2020 Nov 23. | |
| 30470580 |
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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 |
| Tuscon |
| Arizona |
| 85741-1196 |
| United States |
| Research Site | Los Angeles | California | 90015 | United States |
| Research Site | Sacramento | California | 95816 | United States |
| Research Site | San Jose | California | 95124 | United States |
| Research Site | Englewood | Colorado | 80113 | United States |
| Research Site | Dover | Delaware | 19901 | United States |
| Research Site | Jacksonville | Florida | 32209 | United States |
| Research Site | Lighthouse PT | Florida | 33064 | United States |
| Research Site | Port Charlotte | Florida | 33952 | United States |
| Research Site | St. Petersburg | Florida | 33705 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30309 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Savannah | Georgia | 31405 | United States |
| Research Site | Chicago | Illinois | 60637-1463 | United States |
| Research Site | Evanston | Illinois | 60201 | United States |
| Research Site | Franklin | Illinois | 37064 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | Des Moines | Iowa | 50314 | United States |
| Research Site | Lenexa | Kansas | 66214-9836 | United States |
| Research Site | Lexington | Kentucky | 40513 | United States |
| Research Site | Louisville | Kentucky | 40207 | United States |
| Research Site | Baton Rouge | Louisiana | 70810-1686 | United States |
| Research Site | Annapolis | Maryland | 21401 | United States |
| Research Site | Baltimore | Maryland | 21201 | United States |
| Research Site | Lexington | Massachusetts | 02421 | United States |
| Research Site | Springfield | Massachusetts | 01104 | United States |
| Research Site | Worcester | Massachusetts | 01655 | United States |
| Research Site | Clinton Township | Michigan | 48035 | United States |
| Research Site | Muskegon | Michigan | 49444-3719 | United States |
| Research Site | Golden Valley | Minnesota | 55422 | United States |
| Research Site | Columbia | Missouri | 65201 | United States |
| Research Site | Great Falls | Montana | 59405 | United States |
| Research Site | Lincoln | Nebraska | 68506-2960 | United States |
| Research Site | Lincoln | Nebraska | 68521 | United States |
| Research Site | Omaha | Nebraska | 68198 | United States |
| Research Site | Freehold | New Jersey | 07728 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Asheville | North Carolina | 28806 | United States |
| Research Site | Hickory | North Carolina | 28602 | United States |
| Research Site | Raleigh | North Carolina | 27607-6010 | United States |
| Research Site | Akron | Ohio | 44302 | United States |
| Research Site | Canton | Ohio | 44718 | United States |
| Research Site | Centerville | Ohio | 45459 | United States |
| Research Site | Columbus | Ohio | 43221 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Abington | Pennsylvania | 19001 | United States |
| Research Site | Greensburg | Pennsylvania | 15601 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Knoxville | Tennessee | 37934 | United States |
| Research Site | Round Rock | Texas | 78681 | United States |
| Research Site | Salt Lake City | Utah | 84103 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Richmond | Virginia | 23226 | United States |
| Research Site | Bellingham | Washington | 98225 | United States |
| Research Site | Seattle | Washington | 98122 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Neenah | Wisconsin | 54946 | United States |
| Derived |
| Kresa-Reahl K, Repovic P, Robertson D, Okwuokenye M, Meltzer L, Mendoza JP. Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study. Clin Ther. 2018 Dec;40(12):2077-2087. doi: 10.1016/j.clinthera.2018.10.011. Epub 2018 Nov 22. |
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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