Assessment of Patient Use of a New Device: RebiSmart

Multiple Sclerosis Clinical Trial

Official title:

Assessment of Patient Use of a New Device: RebiSmart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195870
• Other study ID #: EMR701068-514
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: February 14, 2014
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have relapsing remitting multiple sclerosis

• Between 18 to 65 years old inclusive

• Have been prescribed Rebif for the first time but not yet started treatment

• Rebismart as chosen device

• Be under review by MS nurse

• Having given written informed consent to participate in the study

Exclusion Criteria:

• Injections of Rebif given by someone other than the patient

• Patients unable to use the Rebismart device due to visual or physical impairment

• Patients unwilling to give informed consent

• Contra-indications to Rebif as defined in the Summary of Product Characteristics (SPC).

• Allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Limited, UK

References & Publications (1)

D'Arcy C, Thomas D, Stoneman D, Parkes L. Patient assessment of an electronic device for subcutaneous self-injection of interferon ß-1a for multiple sclerosis: an observational study in the UK and Ireland. Patient Prefer Adherence. 2012;6:55-61. doi: 10.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of patients who found RebiSmart easy or very easy to use at the end of 12-week treatment period		up to week 16	No
Secondary	Top three functions of the device patients found most useful; top ranked from 1 to 10		up to week 16	No