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lower than anticipated recruitment rate
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This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsing-remitting Multiple Sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RebiSmart®2.0 | Device | Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Relapse-free Subjects | Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate | Annualized relapse rate is calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25. | Months 12 and 24 |
| Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™ |
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Inclusion Criteria:
Exclusion Criteria:
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Participating sites will identify and recruit eligible subjects using appropriate recruitment strategies in accordance with any local approvals/regulations for observational studies e.g. via clinics, referrals, advertisements, patient databases etc.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
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| 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 |
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| MSdialog™ | Device | Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics. |
|
Normalized scores are calculated in the range of 0 - 100; where 0 = the worst QoL status and 100 = the best QoL status (as self-assessed by the subject). |
| Up to 24 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |