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

NCT ID: NCT00292253

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1883 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-remitting

Keywords

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MS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rebif® with Rebiject™Mini

Group Type EXPERIMENTAL

Rebif® via Rebiject™Mini

Intervention Type DEVICE

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

Rebif® without Rebiject™Mini

Group Type ACTIVE_COMPARATOR

Rebif® via manual injections

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Greater than or equal to 18 years of age
* Has relapsing-remitting MS
* Are willing and able to comply with the protocol for the duration of the study

Exclusion Criteria

* Has significant leukopenia/lymphopenia (white blood cell count less than (\<) 0.5 times the lower limit of normal)
* Has elevated liver function tests (aspartate aminotransferase \[AST\], Alanine transaminase \[ALT\], or alkaline phosphatase greater than (\>) 2 times the upper limit of normal or total bilirubin \> 1.5 times the upper limit of normal)
* Has an allergy to human serum albumin or mannitol
* Had treatment with an investigational product or procedure within 3 months
* Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
* Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono International SA

INDUSTRY

Sponsor Role collaborator

EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Lopez-Bresnahan, M.D.

Role: STUDY_DIRECTOR

Merck Serono International SA

References

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Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J; Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005 Oct;11(5):585-91. doi: 10.1191/1352458505ms1197oa.

Reference Type RESULT
PMID: 16193898 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/16193898?dopt=Abstract

Published in Multiple Sclerosis 2005;11:585-591

http://www.mslifelines.com

Full FDA approved prescribing information can be found here

Other Identifiers

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22982

Identifier Type: -

Identifier Source: org_study_id