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

Purpose

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.

Condition
Relapsing Multiple Sclerosis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

Patient Adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Percentage "RebiSmart measured" patient adherence to Rebif® injections

Secondary Outcome Measures:

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

Enrollment:	230
Study Start Date:	March 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601080

Locations

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

Sponsors and Collaborators

Merck KGaA

Merck Serono Limited, UK

More Information

No publications provided

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT01601080 History of Changes
Other Study ID Numbers:	EMR200077-516
Study First Received:	May 15, 2012
Last Updated:	September 27, 2012
Health Authority:	Ireland: Research Ethics Committee United Kingdom: Research Ethics Committee

Keywords provided by Merck KGaA:

Adherence
Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013

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