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Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01195857
First received: August 31, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.

Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]
  • Correlation with recent training within the last 6 months [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]
  • Correlation with disease control (relapse rate) [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]
  • Length of time on treatment [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]
  • Presence of injection site reactions [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]
  • Cognitive impairment [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.

Criteria

Inclusion Criteria:

  • Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
  • Be under regular review by a MS nurse
  • Be aged 18 or above
  • Be willing and able to participate in the trial and to have provided written informed consent

Exclusion Criteria:

  • Receiving disease modifying therapy other than Rebif
  • Receiving Rebif but not using the Rebiject II injection device
  • Do not self inject
  • Are unable or unwilling to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195857

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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01195857     History of Changes
Other Study ID Numbers: EMR701068-512
Study First Received: August 31, 2010
Last Updated: April 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

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 19, 2013