Status:
COMPLETED
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-58 years
Phase:
PHASE2
Brief Summary
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 thi...
Eligibility Criteria
Inclusion
- Key
- 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 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
- 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 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT01864148
Start Date
August 1 2013
End Date
March 1 2016
Last Update
May 3 2017
Active Locations (72)
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1
North Central Neurology Assoc PC
Cullman, Alabama, United States, 35058
2
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
3
Raleigh Neurology Associates PA
Raleigh, California, United States, 27607-6000
4
Stanford University Medical Center
Stanford, California, United States, 94305