NCT01601080

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

May 15, 2012

Last Update Submit

February 3, 2014

Conditions

Relapsing Multiple Sclerosis

Keywords

AdherenceMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Patient Adherence

    Percentage "RebiSmart measured" patient adherence to Rebif® injections

    24 months

Secondary Outcomes (12)

  • Patient Adherence

    1 month

  • Patient Adherence

    3 months

  • Patient Adherence

    6 months

  • Patient Adherence

    12 months

  • Difference in patient adherence over time

    12 months

  • +7 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Please contact the

Merck KGaA Communication Center For Recruiting Locations, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

GB(1)