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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128075
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : July 9, 2014
EMD Inc., Canada
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:

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.

Condition or disease Intervention/treatment
Multiple Sclerosis MS Device: RebiSmart™

Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : August 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Rebif

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Treatment persistence by measuring treatment discontinuations [ Time Frame: 96 weeks ]
  3. Treatment compliance [ Time Frame: 96 weeks ]
    Measuring the number of injections received relative to the time on study

  4. 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)

  5. Longitudinal changes in anxiety symptoms [ Time Frame: 96 weeks ]
    Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)

  6. Qualitative assessment of subjects' experience with RebiSmart [ Time Frame: 96 weeks ]
    A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community and Academic MS clinics

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01128075

University of British Columbia
Vancouver, Canada
Sponsors and Collaborators
Merck KGaA
EMD Inc., Canada
Study Director: Medical Responsible EMD Serono, a division of EMD Inc., Canada

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck KGaA Identifier: NCT01128075     History of Changes
Other Study ID Numbers: EMR701068-520
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Merck KGaA:
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents