An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Completed

• Conditions: Relapsing Multiple Sclerosis

• Registration Number: NCT01601080
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This is an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Primary Completion: 2012-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
• Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
• Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
• Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
• Be willing to give consent for their adherence data to be captured in the audit

Exclusion Criteria

Patients who do not fulfill entirely the inclusion criteria as well as the following:

• Discontinued Rebif before 24 months of treatment
• Unable or unwilling to give consent for their adherence data to be captured in the audit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Adherence	24 months	Percentage "RebiSmart measured" patient adherence to Rebif® injections

Secondary Outcome Measures

Name	Time	Method
Patient Adherence	12 months	Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
Difference in patient adherence over time	12 months	Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.
Medication Possession Ratio	24 months	Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
Adherence of patient subgroups	24 months	"RebiSmart™ measured" percentage adherence within and between the following patient sub-groups: * patients who are and are not registered to MySupport (Rebif Support Programme); * patient age groups; * patient gender; * prior use of a DMT
Patient Adherence in the UK versus Ireland	24 months	Reporting of UK and Ireland actual adherence levels separately
Device Comfort Settings	12 months	Preferred final comfort settings (at last injection)

Trial Locations

Locations (1)

Please contact the; 🇬🇧 Merck KGaA Communication Center for recruiting locations, United Kingdom