Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 58
Updated:4/21/2016
Start Date:August 2013
End Date:March 2016

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants
with active relapsing MS when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety,
tolerability, and population PK of BIIB033 when used concurrently with Avonex


Key Inclusion Criteria:

- Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or onset of Secondary
Progressive Multiple Sclerosis (SPMS)

- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12
months of enrollment.

- All male and female subjects of childbearing potential must practice effective
contraception during the study and be willing and able to continue contraception for
at least 6 months after their last dose of study treatment

Key Exclusion Criteria:

- A Multiple Sclerosis (MS) relapse that has occurred within the 90 days prior to Day
1/Baseline and/or the subject has not stabilized from a previous relapse prior to
Screening

- Previous history of clinically significant disease.

- Plans to undergo elective major procedures/surgeries at any time during the study.

- Treatment with any investigational Multiple Sclerosis (MS) drugs within 3 weeks or 5
times the half life (whichever is longer) prior to Day 1/Baseline

- Relapsing Remitting Multiple Sclerosis (RRMS) subjects with any history of inadequate
response to any approved interferon β preparation

- History of Human Immunodeficiency Virus (HIV), hepatitis C virus antibody, or
hepatitis B virus

- History or evidence of drug or alcohol abuse within 2 years prior to Randomization

Note: Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
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5090 N 40th St # 250
Phoenix, Arizona 85018
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Centennial, Colorado 80112
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Cullman, Alabama 35058
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Farmington Hills, Michigan 48334
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London,
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Raleigh, California 27607
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Saint Louis, Missouri 63110
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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