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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00292266
First received: February 13, 2006
Last updated: March 21, 2009
Last verified: March 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMD Serono:

  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

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

Keywords provided by EMD Serono:
Relapsing-remitting MS

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013