Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects (MEASURE)

July 8, 2014 updated by: Merck KGaA, Darmstadt, Germany

Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)

This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).

Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.

The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community and Academic MS clinics

Description

Inclusion Criteria:

  • Males and females between 18 and 65 years of age.
  • Have RMS according to the revised McDonald Criteria.
  • Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
  • Be willing and able to comply with the protocol requirements for the duration of the study.
  • Have given written informed consent prior to entering the screening period.
  • Must register with the Rebif® Multiple Support Program.
  • Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.

Exclusion Criteria:

  • Have any disease other than MS that could better explain his/her signs and symptoms.
  • Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
  • Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
  • Have a diagnosis of clinically isolated syndrome (CIS).
  • Participation in any other investigational trial prior to 30 days of Study Day 1.
  • Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
  • Have received previous treatment with Rebif within 5 years prior to screening.
  • Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
naïve subjects
Cohort of RMS patients who initiate disease modifying treatment with Rebif®
Device: RebiSmart™
Electronic self-injection device (RebiSmart™) to inject Rebif®
Other Names:
  • Rebif
non-naïve subjects
Cohort of RMS patients who initiate treatment with Rebif® after having failed therapy with other disease modifying drugs on the basis of lack of efficacy, compliance, safety, tolerability or convenience, as per clinical judgment of study investigator
Device: RebiSmart™
Electronic self-injection device (RebiSmart™) to inject Rebif®
Other Names:
  • Rebif

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.
Time Frame: 96 weeks
96 weeks
Treatment persistence by measuring treatment discontinuations
Time Frame: 96 weeks
96 weeks
Treatment compliance
Time Frame: 96 weeks
Measuring the number of injections received relative to the time on study
96 weeks
Comparison of subject treatment adherence between categories of cognitive function
Time Frame: 96 weeks
Measured by the short version of Rao's Brief Repeatable Battery (BRB)
96 weeks
Longitudinal changes in anxiety symptoms
Time Frame: 96 weeks
Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)
96 weeks
Qualitative assessment of subjects' experience with RebiSmart
Time Frame: 96 weeks
A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

EMD Inc., Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR701068-520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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