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Assessment of Patient Use of a New Device: RebiSmart

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01195870
First received: August 31, 2010
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Patient Use of a New Device: RebiSmart

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Top three functions of the device patients found most useful; top ranked from 1 to 10 [ Time Frame: up to week 16 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195870

Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
Investigators
Study Director: Dr Gillian L Shepherd, MD, MRCP Merck Serono Limited, UK
  More Information

Publications:

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01195870     History of Changes
Other Study ID Numbers: EMR701068-514
Study First Received: August 31, 2010
Last Updated: March 14, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Merck KGaA:
Multiple sclerosis
Rebif
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013