Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Serono Limited, UK | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse.
Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times a week by injections under the skin. The RebiSmart device is a new injection device which has been developed to help patients with injecting their Rebif treatment.
Currently, all treatments for MS are injectable and require long term patient commitment. Patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. Using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. The RebiSmart device has been developed for patients to inject conveniently and in comfort. The device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on-screen injection guide. The aim of this study is to determine what percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study will also determine which of the device features were most useful to the patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who liked using the RebiSmart device based on a score of 6 or more on a Visual Analogue Scale (VAS) at the end of 12-week treatment period | up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who found RebiSmart easy or very easy to use at the end of 12-week treatment period | up to week 16 | |
| Top three functions of the device patients found most useful; top ranked from 1 to 10 | up to week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients, who are under regular review by a Multiple Sclerosis nurse, with relapsing remitting multiple sclerosis who have been prescribed Rebif and have chosen to use the RebiSmart device for drug administration.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Gillian L Shepherd, MD, MRCP | Merck Serono Limited, UK | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22298944 | Result | D'Arcy C, Thomas D, Stoneman D, Parkes L. Patient assessment of an electronic device for subcutaneous self-injection of interferon beta-1a for multiple sclerosis: an observational study in the UK and Ireland. Patient Prefer Adherence. 2012;6:55-61. doi: 10.2147/PPA.S26250. Epub 2012 Jan 18. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |