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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-BGT-14-10614 | Other Identifier | Sponsor |
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109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.
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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-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment naive to 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. |
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| Switch to 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | administered according to the local product label (i.e., Canadian Product Monograph). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) at month 12 | Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score | 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 and month 12 |
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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-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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edmonton | Alberta | T6G 2G3 | Canada | ||
| Research Site |
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|
| Change from baseline to Month 12 in the 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 and month 12 |
| Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores | 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. | Baseline and month 12 |
| Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores | BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale. | Baseline and month 12 |
| Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores | WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis | Baseline and month 12 |
| Change from baseline to Month 12 in the 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 and month 12 |
| Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores | 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. | Baseline and month 12 |
| Proportion of patients relapsing at Month 12 | Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours. | Month 12 |
| Proportion of patients with relapses associated with hospitalizations at Month 12 | Month 12 |
| Proportion of patients with relapses associated with steroid use at Month 12 | Month 12 |
| Burnaby |
| British Columbia |
| V5G 2X6 |
| Canada |
| Research Site | Saint John | New Brunswick | E2L 4L2 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Research Site | Halifax | Nova Scotia | B3H 4K4 | Canada |
| Research Site | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Research Site | Cambridge | Ontario | N1R 7L6 | Canada |
| Research Site | London | Ontario | N6A 5A5 | Canada |
| Research Site | Gatineau | Quebec | J9J 0A5 | Canada |
| Research Site | Montreal | Quebec | H3A 2B4 | Canada |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 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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