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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01601080
First received: May 15, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition
Relapsing Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Patient Adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percentage "RebiSmart measured" patient adherence to Rebif® injections


Secondary Outcome Measures:
  • Patient Adherence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Percentage "RebiSmart measured" patient adherence to Rebif® injections

  • Patient Adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  • Patient Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  • Patient Adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage "RebiSmart™ measured" patient adherence to Rebif® injections

  • Difference in patient adherence over time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.

  • Medication Possession Ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels

  • Medication Possession Ratio [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels

  • Adherence of patient subgroups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    "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

  • Adherence of patient subgroups [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    "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

  • Patient Adherence in the UK versus Ireland [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reporting of UK and Ireland actual adherence levels separately

  • Patient Adherence in the UK versus Ireland [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Reporting of UK and Ireland actual adherence levels separately

  • Device Comfort Settings [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Preferred final comfort settings (at last injection)


Enrollment: 230
Study Start Date: April 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601080

Locations
United Kingdom
Please contact the
Merck KGaA Communication Center for recruiting locations, United Kingdom
Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01601080     History of Changes
Other Study ID Numbers: EMR200077-516
Study First Received: May 15, 2012
Last Updated: February 3, 2014
Health Authority: Ireland: Research Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Merck KGaA:
Adherence
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014