An Observational, Retrospective, UK & Ireland Audit of Pa... | NCT01601080

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

NCT01601080

Sponsor

Merck KGaA, Darmstadt, Germany

Status

Completed

Last Update Posted

Feb 4, 2014Estimated

Enrollment

230Actual

Phase

Not provided

Conditions

Relapsing Multiple Sclerosis

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Not provided

First Submitted Date

May 15, 2012

First Submission Date that Met QC Criteria

May 16, 2012

First Posted Date

May 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2014

Last Update Posted Date

Feb 4, 2014Estimated

Name	Class
Merck Serono Limited, UK	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Patient Adherence	Percentage "RebiSmart measured" patient adherence to Rebif® injections	1 month
Patient Adherence	Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Please contact the		Merck KGaA Communication Center For Recruiting Locations			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided