Assessment of Patient Use of a New Device: RebiSmart

February 14, 2014 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: up to week 16
up to week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who found RebiSmart easy or very easy to use at the end of 12-week treatment period
Time Frame: up to week 16
up to week 16
Top three functions of the device patients found most useful; top ranked from 1 to 10
Time Frame: up to week 16
up to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Limited, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR701068-514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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