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

NCT ID: NCT01601080

Last Updated: 2014-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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Conditions

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Relapsing Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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


* Discontinued Rebif before 24 months of treatment
* Unable or unwilling to give consent for their adherence data to be captured in the audit
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono Limited, UK

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Please contact the

Merck KGaA Communication Center For Recruiting Locations, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EMR200077-516

Identifier Type: -

Identifier Source: org_study_id

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