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

February 3, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Merck KGaA Communication Center for recruiting locations, United Kingdom
        • Please contact the

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Relapsing Multiple Sclerosis who have been prescribed Rebif® (22mcg or 44mcg)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Adherence
Time Frame: 24 months
Percentage "RebiSmart measured" patient adherence to Rebif® injections
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Adherence
Time Frame: 1 month
Percentage "RebiSmart measured" patient adherence to Rebif® injections
1 month
Patient Adherence
Time Frame: 3 months
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
3 months
Patient Adherence
Time Frame: 6 months
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
6 months
Patient Adherence
Time Frame: 12 months
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
12 months
Difference in patient adherence over time
Time Frame: 12 months
Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.
12 months
Medication Possession Ratio
Time Frame: 12 months
Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
12 months
Medication Possession Ratio
Time Frame: 24 months
Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
24 months
Adherence of patient subgroups
Time Frame: 12 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
12 months
Adherence of patient subgroups
Time Frame: 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
24 months
Patient Adherence in the UK versus Ireland
Time Frame: 12 months
Reporting of UK and Ireland actual adherence levels separately
12 months
Patient Adherence in the UK versus Ireland
Time Frame: 24 months
Reporting of UK and Ireland actual adherence levels separately
24 months
Device Comfort Settings
Time Frame: 12 months
Preferred final comfort settings (at last injection)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Limited, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200077-516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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