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OpenTrials
Completed

NCT Number: NCT01195870

Assessment of Patient Use of a New Device: RebiSmart

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Top three functions of the device patients found most useful; top ranked from 1 to 10

    Time frame: up to week 16

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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