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| Name | Class |
|---|---|
| Merck Serono Limited, UK | INDUSTRY |
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Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.
Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse | up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist | up to 6 month | |
| Correlation with recent training within the last 6 months | up to 6 month | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Gillian L Shepherd, MD, MRCP | Merck Serono Limited, UK | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31 |
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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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| Correlation with disease control (relapse rate) |
| up to 6 month |
| Length of time on treatment | up to 6 month |
| Presence of injection site reactions | up to 6 month |
| Cognitive impairment | up to 6 month |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |