Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

Multiple Sclerosis Clinical Trial

— MEASURE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128075
• Other study ID #: EMR701068-520
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: July 8, 2014
• Start date: August 2009
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• MS
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• RebiSmart™
Electronic self-injection device (RebiSmart™) to inject Rebif®
• RebiSmart™
Electronic self-injection device (RebiSmart™) to inject Rebif®

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	EMD Inc., Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.		24 weeks	No
Secondary	Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.		96 weeks	No
Secondary	Treatment persistence by measuring treatment discontinuations		96 weeks	No
Secondary	Treatment compliance	Measuring the number of injections received relative to the time on study	96 weeks	No
Secondary	Comparison of subject treatment adherence between categories of cognitive function	Measured by the short version of Rao's Brief Repeatable Battery (BRB)	96 weeks	No
Secondary	Longitudinal changes in anxiety symptoms	Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)	96 weeks	No
Secondary	Qualitative assessment of subjects' experience with RebiSmart	A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.	96 weeks	No