Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

NCT01128075 | Completed

• 1 other identifier: EMR701068-520
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; MS

Keywords

RebiSmart; Rebif; Adherence; Multidose; Relapsing Multiple Sclerosis; RMS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• Treatment persistence by measuring treatment discontinuations

  96 weeks

• Treatment compliance

  96 weeks

• Comparison of subject treatment adherence between categories of cognitive function

  96 weeks

• Longitudinal changes in anxiety symptoms

  96 weeks

Study Arms (2)

naïve subjects

Cohort of RMS patients who initiate disease modifying treatment with Rebif®

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

Device: RebiSmart™

Interventions

RebiSmart™ DEVICE

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

Also known as: Rebif

naïve subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community and Academic MS clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• EMD Inc., Canada: collaborator

Study Sites (1)

University of British Columbia

Vancouver, Canada

Location

Related Publications (1)

• Devonshire VA, Feinstein A, Moriarty P. Adherence to interferon beta-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study. BMC Res Notes. 2016 Mar 8;9:148. doi: 10.1186/s13104-016-1948-z.

  PMID: 26951043 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  EMD Serono, a division of EMD Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

CA (1)