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This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.
Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monomethyl Fumarate | Drug | 95 mg oral capsule, 190 mg (2 x 95 mg) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants on treatment with Bafiertam at 1 Year. | Percentage of participants on treatment with Bafiertam at 1 Year. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants on Treatment with Bafiertam at 6 months | Percentage of Participants on Treatment with Bafiertam at 6 months | 6 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be selected from existing patients known to the individual investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Lategan, PhD | Banner Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert Neurology | Gilbert | Arizona | 85297 | United States | ||
| Center for Neurology and Spine |
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score (range 0 - 100) at Month 6 and 12 months.TSQM Version 9 is comprised of 9 questions that provide scores on four scales: effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.
| 12 months |
| Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation. | Number of Participants with AEs Leading to Treatment Discontinuation. | 12 months |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Perseverance Research Center, LLC | Scottsdale | Arizona | 85253 | United States |
| Clinical Endpoints | Scottsdale | Arizona | 85258 | United States |
| Regina Berkovich MD PhD Inc. | West Hollywood | California | 90048 | United States |
| Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Maryland Center for Neurology and Sleep | Glen Burnie | Maryland | 21061 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Caribbean Center for Clinical Research/San Juan MS Center | San Juan | Puerto Rico |
| 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 |
|---|---|
| C509058 | monomethyl fumarate |
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