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Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

NCT01128075 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2014-07-09

No results posted yet for this study

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

Interventions

DEVICE

RebiSmart™

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

DEVICE

RebiSmart™

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

Sponsors & Collaborators

  • EMD Inc., Canada

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono, a division of EMD Inc., Canada

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128075 on ClinicalTrials.gov