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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: February 3, 2014
Last verified: February 2014

August 31, 2010
February 3, 2014
January 2009
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01195857 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Multiple Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01195857
EMR701068-512
No
Merck KGaA
Merck KGaA
Merck Serono Limited, UK
Study Director: Dr Gillian L Shepherd, MD, MRCP Merck Serono Limited, UK
Merck KGaA
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP