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

NCT00292266 | Completed Phase 3

• 1 other identifier: 21125
• Study Type: interventional
• Target: 677
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing-remitting Multiple Sclerosis; Rebif®; Avonex®; interferon-beta-1a

Outcome Measures

Primary Outcomes (3)

• Percentage of exacerbation-free subjects

  Week 24

• Percentage of exacerbation-free subjects

  Week 48

• Percentage of exacerbation-free subjects

  Week 72

Secondary Outcomes (3)

• Mean number of combined unique (CU) active lesions per subject per scan

  Week 24

• Total exacerbation count per subject

  Week 24, 48 and 72

• Mean Number of Time constant 2 (T2) active lesions per subject per scan

  Week 24, 48 and 72

Study Arms (2)

Rebif®

EXPERIMENTAL

Drug: Rebif®

Avonex®

ACTIVE COMPARATOR

Drug: Avonex®

Interventions

Rebif® DRUG

Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.

Rebif®

Avonex® DRUG

Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.

Avonex®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• EMD Serono: lead
• Merck Serono International SA: collaborator

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Gordon Francis, M.D.

  Merck Serono International SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: November 1, 1999
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: August 5, 2013

Record last verified: 2013-08