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Clinical Trials/NCT01195857
NCT01195857
Completed
Not Applicable

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

Merck KGaA, Darmstadt, Germany0 sites100 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Merck KGaA, Darmstadt, Germany
Enrollment
100
Primary Endpoint
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
September 2009
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Correlation with disease control (relapse rate)(up to 6 month)
  • Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist(up to 6 month)
  • Length of time on treatment(up to 6 month)
  • Cognitive impairment(up to 6 month)
  • Correlation with recent training within the last 6 months(up to 6 month)
  • Presence of injection site reactions(up to 6 month)

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