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OpenTrials
Completed

NCT Number: NCT01195857

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.

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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 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

Treatment and study plan

Primary outcomes

  1. 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

  1. Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist

    Time frame: up to 6 month

  2. Correlation with recent training within the last 6 months

    Time frame: up to 6 month

  3. Correlation with disease control (relapse rate)

    Time frame: up to 6 month

  4. Length of time on treatment

    Time frame: up to 6 month

  5. Presence of injection site reactions

    Time frame: up to 6 month

  6. Cognitive impairment

    Time frame: up to 6 month

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 6, 2010
Registry last updated
Feb 4, 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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