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

NCT01195857 | Completed

• 1 other identifier: EMR701068-512
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Rebif; Interferon beta-1a

Outcome Measures

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

  up to 6 month

Secondary Outcomes (6)

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

  up to 6 month

• Correlation with recent training within the last 6 months

  up to 6 month

• Correlation with disease control (relapse rate)

  up to 6 month

• Length of time on treatment

  up to 6 month

• Presence of injection site reactions

  up to 6 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Limited, UK: collaborator

Related Publications (1)

• Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31

  RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr Gillian L Shepherd, MD, MRCP

  Merck Serono Limited, UK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 6, 2010
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 4, 2014

Record last verified: 2014-02