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

May 20, 2010
July 8, 2014
August 2009
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01128075 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Community and Academic MS clinics

  • Multiple Sclerosis
  • MS
Device: RebiSmart™
Electronic self-injection device (RebiSmart™) to inject Rebif®
Other Name: Rebif
  • naïve subjects
    Cohort of RMS patients who initiate disease modifying treatment with Rebif®
    Intervention: Device: RebiSmart™
  • 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
    Intervention: Device: RebiSmart™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01128075
EMR701068-520
No
Merck KGaA
Merck KGaA
EMD Inc., Canada
Study Director: Medical Responsible EMD Serono, a division of EMD Inc., Canada
Merck KGaA
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP