An observational study in Multiple Sclerosis, sponsored by Merck KGaA, Darmstadt, Germany. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-04.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist
Time frame: up to 6 month
Correlation with recent training within the last 6 months
Time frame: up to 6 month
Correlation with disease control (relapse rate)
Time frame: up to 6 month
Length of time on treatment
Time frame: up to 6 month
Presence of injection site reactions
Time frame: up to 6 month
Cognitive impairment
Time frame: up to 6 month
No study locations are listed for this record.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany