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

This study has been completed.

First Received: February 13, 2006 Last Updated: March 21, 2009 History of Changes

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00292253

Purpose

A randomized, multicenter, parallel-group open-label study comparing the tolerability of Rebif® injections (44 mcg administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting MS patients. Patients were randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by centre. Patients were to receive a minimum of three months of treatment with Rebif® 44 mcg tiw and were asked to assess their injection site reactions on a weekly basis. Clinic visit occurred one and three months after the initiation of treatment

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Device: Rebiject™ Mini Procedure: manual injections	Phase IV

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

≥18 years of age
Relapsing-remitting MS
Willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292253

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Maria Lopez-Bresnahan, M.D.

EMD Serono

More Information

Additional Information:

Published in Multiple Sclerosis 2005;11:585-591 This link exits the ClinicalTrials.gov site

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	22982
Study First Received:	February 13, 2006
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00292253 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Serono:

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta 1a

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009