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

This study has been completed.

Sponsor:

Collaborator:

Merck Serono Limited, UK

Information provided by (Responsible Party):

Merck KGaA

ClinicalTrials.gov Identifier:

NCT01601080

First received: May 15, 2012

Last updated: September 27, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 15, 2012
Last Updated Date	September 27, 2012
Start Date ^ICMJE	March 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2012)	Patient Adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ] Percentage "RebiSmart measured" patient adherence to Rebif® injections
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01601080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 16, 2012)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
Official Title ^ICMJE	REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with Relapsing Multiple Sclerosis who have been prescribed Rebif® (22mcg or 44mcg)
Condition ^ICMJE	Relapsing Multiple Sclerosis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	230
Completion Date	Not Provided
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01601080
Other Study ID Numbers ^ICMJE	EMR200077-516
Has Data Monitoring Committee	No
Responsible Party	Merck KGaA
Study Sponsor ^ICMJE	Merck KGaA
Collaborators ^ICMJE	Merck Serono Limited, UK
Investigators ^ICMJE	Not Provided
Information Provided By	Merck KGaA
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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