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Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Trial ID: NCT01864148
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
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
Key Inclusion Criteria:
- Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months
- 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 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 MS drugs within 3 weeks or 5 times the half life
(whichever is longer) prior to Day 1/Baseline
- RRMS subjects with any history of inadequate response to any approved interferon β
- 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.
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Viet Nguyen, MD