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

This study has been completed.
Sponsor:
Collaborator:
Serono International S.A.
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00292266
First received: February 13, 2006
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Rebif®
Drug: Avonex®
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:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percentage of exacerbation-free subjects [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of exacerbation-free subjects [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of exacerbation-free subjects [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of combined unique (CU) active lesions per subject per scan [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Total exacerbation count per subject [ Time Frame: Week 24, 48 and 72 ] [ Designated as safety issue: No ]
  • Mean Number of Time constant 2 (T2) active lesions per subject per scan [ Time Frame: Week 24, 48 and 72 ] [ Designated as safety issue: No ]

Enrollment: 677
Study Start Date: November 1999
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebif® Drug: Rebif®
Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.
Active Comparator: Avonex® Drug: Avonex®
Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 55 years
  • Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria
  • Two or more relapses within the preceding 24 months
  • Clinical stability or improving neurological state during the 4 weeks before Study Day 1
  • Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive
  • Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI
  • Willingness and ability to comply with the protocol for the duration of the study
  • Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care
  • For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized)

Exclusion Criteria:

  • Secondary progressive MS, primary progressive MS or progressive relapsing MS
  • Prior use of interferon
  • Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI
  • Psychiatric disorder that is unstable or will preclude safe participation in the study
  • Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1
  • Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 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, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone
  • Previous use of cladribine or total lymphoid irradiation
  • Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA)
  • Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1
  • Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292266

Sponsors and Collaborators
EMD Serono
Serono International S.A.
Investigators
Study Director: Gordon Francis, M.D. Merck Serono International SA
  More Information

Additional Information:
No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00292266     History of Changes
Other Study ID Numbers: 21125
Study First Received: February 13, 2006
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Relapsing-remitting Multiple Sclerosis
Rebif®
Avonex®
interferon-beta-1a

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 April 17, 2014