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Rebif® Rebidose® Versus Rebiject II® Ease-of-Use

NCT02019550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-03-07

Study results available
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Summary

This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DEVICE

Rebif Rebidose

Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.

DEVICE

Rebiject II

Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02019550 on ClinicalTrials.gov