Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

NCT ID: NCT01128075

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

naïve subjects

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

RebiSmart™

Intervention Type: DEVICE

Electronic self-injection device (RebiSmart™) to inject 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

RebiSmart™

Intervention Type: DEVICE

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

Interventions

RebiSmart™

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

Intervention Type: DEVICE

RebiSmart™

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

Intervention Type: DEVICE

Other Intervention Names

Rebif; Rebif

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMD Inc., Canada

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, a division of EMD Inc., Canada

Locations

University of British Columbia

Vancouver, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26951043 (View on PubMed)

Other Identifiers

EMR701068-520

Identifier Type: -

Identifier Source: org_study_id