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Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

NCT00292253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1883

Last updated 2013-08-06

No results posted yet for this study

Summary

This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram \[mcg\] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.

Conditions

  • Multiple Sclerosis, Relapsing-remitting

Interventions

DEVICE

Rebif® via Rebiject™Mini

Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.

DEVICE

Rebif® via manual injections

Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • EMD Serono

    lead INDUSTRY

Principal Investigators

  • Maria Lopez-Bresnahan, M.D. · Merck Serono International SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2002-12-31
Completion
2002-12-31

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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 NCT00292253 on ClinicalTrials.gov