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The Multicenter, Open-label, Single-use Autoinjector Convenience Study

NCT00958009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2013-08-07

Study results available
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Summary

The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).

Conditions

Interventions

DEVICE

Rebidose®

The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection

Sponsors & Collaborators

Principal Investigators

  • Fernando Dangond, MD · EMD Serono

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00958009 on ClinicalTrials.gov