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

This study has been completed.
Sponsor:
Collaborator:
EMD Inc., Canada
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01128075
First received: May 20, 2010
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Multiple Sclerosis
MS
Device: RebiSmart™

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Treatment persistence by measuring treatment discontinuations [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Treatment compliance [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Measuring the number of injections received relative to the time on study

  • Comparison of subject treatment adherence between categories of cognitive function [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Measured by the short version of Rao's Brief Repeatable Battery (BRB)

  • Longitudinal changes in anxiety symptoms [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)

  • Qualitative assessment of subjects' experience with RebiSmart [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.


Enrollment: 198
Study Start Date: August 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community and Academic MS clinics

Criteria

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.
  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: NCT01128075

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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01128075     History of Changes
Other Study ID Numbers: EMR701068-520
Study First Received: May 20, 2010
Last Updated: July 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck KGaA:
RebiSmart
Rebif
Adherence
Multidose
Relapsing Multiple Sclerosis
RMS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014