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| Name | Class |
|---|---|
| Merck Serono Norway | INDUSTRY |
| Smerud Medical Research International AS | OTHER |
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The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RebiSmart | Device | Treatment with Rebif New Formulation using RebiSmart. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence assessment | Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS | 12 weeks |
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Inclusion Criteria:
Males and females between 18 and 65 years of age
Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
Have a scheduled visit 12 weeks after the inclusion visit
Willing and able to comply with the protocol for the duration of the study
Have given written informed consent
Exclusion Criteria:
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Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Serono Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandvika Nevrosenter | Sandvika | Sandviksveien 178 | N-1337 | Norway |
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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 |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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