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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Relapsing Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01601080

EMR200077-516

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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