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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebif® with Rebiject™Mini | Experimental |
| |
| Rebif® without Rebiject™Mini | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif® via Rebiject™Mini | Device | Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with any injection site reactions based on physician assessment | Month 3 | |
| Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports | Baseline up to Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Lopez-Bresnahan, M.D. | Merck Serono International SA | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16193898 | Result | Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J; Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005 Oct;11(5):585-91. doi: 10.1191/1352458505ms1197oa. |
| Label | URL |
|---|---|
| Published in Multiple Sclerosis 2005;11:585-591 | View source |
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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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| Rebif® via manual injections | Device | Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months. |
|
| Percentage of injection site reactions reported per subject based on subject reports | Baseline up to Month 3 |
| Full FDA approved prescribing information can be found here | View source |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |