A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-Remitting Multiple Sclerosis (MS)

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:	NCT00292266

Purpose

This was an open-label, randomized, multicenter, comparative, parallel-group study comparing the therapeutic effects of two IFN-beta-1a regimens in relapsing-remitting multiple sclerosis. The primary objective was to demonstrate the superiority of Rebi®f 44 mcg SC given three times a week (132 mcg per week) to that of Avonex® 30 mcg IM given once a week.

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Rebif® 44 mcg three times per week subcutaneously (SubQ) Drug: Avonex® 30 mcg once weekly intramuscularly (IM)	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-Remitting Multiple Sclerosis

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Age between 18 and 55 years
Clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis according to Poser's criteria
Two or more relapses within the preceding 24 months
Clinical stability or improving neurological state during the four weeks before Study Day 1
EDSS score from 0 to 5.5, inclusive
Two or more lesions consistent with MS on a screening PD/T2 MRI scan to be performed 28 ± 4 days before the Study Day 1 (baseline) MRI

Exclusion Criteria:

Secondary progressive MS, primary progressive MS or progressive relapsing MS
Prior use of interferon
Treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 or within 7 days before the screening MRI
Significant leucopenia (white blood cell count <0.5 times the lower limit of normal) within 7 days of Study Day 1
Elevated liver function tests (ALT, AST, alkaline phosphatase or total bilirubin >2 times the upper limit of normal) within 7 days of Study Day 1
Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1
Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1
Previous use of cladribine or total lymphoid irradiation iv immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292266

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Gordon Francis, M.D.

EMD Serono

More Information

Additional Information:

Published in Neurology 2002;59:1496-1506 This link exits the ClinicalTrials.gov site

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

No publications provided

Study ID Numbers:	21125
Study First Received:	February 13, 2006
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00292266 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Serono:

Relapsing-remitting MS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic

Interferon-beta
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Sclerosis

Multiple Sclerosis, Relapsing-Remitting
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009