MedTrace Logo

Assessment of Patient Use of a New Device: RebiSmart

NCT01195870 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2014-02-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Merck Serono Limited, UK

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Dr Gillian L Shepherd, MD, MRCP · Merck Serono Limited, UK

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30
Completion
2010-10-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195870 on ClinicalTrials.gov