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Completed

NCT Number: NCT01601080

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

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.

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Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Please contact the

Merck KGaA Communication Center For Recruiting Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient Adherence

    Time frame: 24 months

    Percentage "RebiSmart measured" patient adherence to Rebif® injections

Secondary outcomes

  1. Patient Adherence

    Time frame: 1 month

    Percentage "RebiSmart measured" patient adherence to Rebif® injections

  2. Patient Adherence

    Time frame: 3 months

    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  3. Patient Adherence

    Time frame: 6 months

    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  4. Patient Adherence

    Time frame: 12 months

    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  5. Difference in patient adherence over time

    Time frame: 12 months

    Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.

  6. Medication Possession Ratio

    Time frame: 12 months

    Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels

  7. Medication Possession Ratio

    Time frame: 24 months

    Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels

  8. Adherence of patient subgroups

    Time frame: 12 months

    "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

  9. Adherence of patient subgroups

    Time frame: 24 months

    "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

  10. Patient Adherence in the UK versus Ireland

    Time frame: 12 months

    Reporting of UK and Ireland actual adherence levels separately

  11. Patient Adherence in the UK versus Ireland

    Time frame: 24 months

    Reporting of UK and Ireland actual adherence levels separately

  12. Device Comfort Settings

    Time frame: 12 months

    Preferred final comfort settings (at last injection)

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Official study title

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

Acronym: READER

Important dates

Study start
2012
Primary completion
2012
First posted
May 17, 2012
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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