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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292266
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : August 5, 2013
Merck Serono International SA
Information provided by (Responsible Party):
EMD Serono

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Rebif® Drug: Avonex® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 677 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 1999
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Percentage of exacerbation-free subjects [ Time Frame: Week 24 ]
  2. Percentage of exacerbation-free subjects [ Time Frame: Week 48 ]
  3. Percentage of exacerbation-free subjects [ Time Frame: Week 72 ]

Secondary Outcome Measures :
  1. Mean number of combined unique (CU) active lesions per subject per scan [ Time Frame: Week 24 ]
  2. Total exacerbation count per subject [ Time Frame: Week 24, 48 and 72 ]
  3. Mean Number of Time constant 2 (T2) active lesions per subject per scan [ Time Frame: Week 24, 48 and 72 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292266

Sponsors and Collaborators
EMD Serono
Merck Serono International SA
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Study Director: Gordon Francis, M.D. Merck Serono International SA
Additional Information:
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Responsible Party: EMD Serono Identifier: NCT00292266    
Other Study ID Numbers: 21125
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
Keywords provided by EMD Serono:
Relapsing-remitting Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents