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| Name | Class |
|---|---|
| EMD Inc., Canada | INDUSTRY |
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This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naïve subjects | Cohort of RMS patients who initiate disease modifying treatment with Rebif® |
| |
| non-naïve subjects | Cohort of RMS patients who initiate treatment with Rebif® after having failed therapy with other disease modifying drugs on the basis of lack of efficacy, compliance, safety, tolerability or convenience, as per clinical judgment of study investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RebiSmart™ | Device | Electronic self-injection device (RebiSmart™) to inject Rebif® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge. | 96 weeks | |
| Treatment persistence by measuring treatment discontinuations | 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Community and Academic MS clinics
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono, a division of EMD Inc., Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26951043 | Derived | Devonshire VA, Feinstein A, Moriarty P. Adherence to interferon beta-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study. BMC Res Notes. 2016 Mar 8;9:148. doi: 10.1186/s13104-016-1948-z. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| RebiSmart™ | Device | Electronic self-injection device (RebiSmart™) to inject Rebif® |
|
|
| Treatment compliance | Measuring the number of injections received relative to the time on study | 96 weeks |
| Comparison of subject treatment adherence between categories of cognitive function | Measured by the short version of Rao's Brief Repeatable Battery (BRB) | 96 weeks |
| Longitudinal changes in anxiety symptoms | Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI) | 96 weeks |
| Qualitative assessment of subjects' experience with RebiSmart | A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment. | 96 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |