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NCT01601080 Clinical Trial

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

Relapsing Multiple Sclerosis Clinical Trial

— READER  

Official title:
REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01601080
Other study ID # EMR200077-516
Secondary ID
Status Completed
Phase N/A
First received May 15, 2012
Last updated February 3, 2014
Start date April 2012

Study information
Verified date February 2014
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics CommitteeUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 230
Est. completion date
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Please contact the Merck KGaA Communication Center for recruiting locations

Sponsors (2)
Lead Sponsor Collaborator
Merck KGaA Merck Serono Limited, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Adherence Percentage "RebiSmart measured" patient adherence to Rebif® injections 24 months No
Secondary Patient Adherence Percentage "RebiSmart measured" patient adherence to Rebif® injections 1 month No
Secondary Patient Adherence Percentage "RebiSmart™ measured" patient adherence to Rebif® injections 3 months No
Secondary Patient Adherence Percentage "RebiSmart™ measured" patient adherence to Rebif® injections 6 months No
Secondary Patient Adherence Percentage "RebiSmart™ measured" patient adherence to Rebif® injections 12 months No
Secondary Difference in patient adherence over time Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period. 12 months No
Secondary Medication Possession Ratio Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels 12 months No
Secondary Medication Possession Ratio Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels 24 months No
Secondary Adherence of patient subgroups "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		 12 months No
Secondary Adherence of patient subgroups "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		 24 months No
Secondary Patient Adherence in the UK versus Ireland Reporting of UK and Ireland actual adherence levels separately 12 months No
Secondary Patient Adherence in the UK versus Ireland Reporting of UK and Ireland actual adherence levels separately 24 months No
Secondary Device Comfort Settings Preferred final comfort settings (at last injection) 12 months No
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