Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:May 2010
End Date:July 2014

Use our guide to learn which trials are right for you!

Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC
HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in
participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a
in slowing functional decline and disability progression and maintaining quality of life in
this participant population.


Key Inclusion Criteria:

- Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and
a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS

- Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0,
inclusive

- Male subjects and female subjects of childbearing potential must be willing to
practice effective contraception during the study and be willing and able to continue
contraception for 4 months after their last dose of study treatment

Key Exclusion Criteria:

- Known intolerance, contraindication to, or history of non-compliance with Avonex® 30
µg

- History of treatment with Daclizumab High Yield Process (Dac HYP)

- History of malignancy

- History of severe allergic or anaphylactic reactions

- Known hypersensitivity to study drugs or their excipients

- History of abnormal laboratory results indicative of any significant disease

- History of human immunodeficiency virus (HIV) or other immunodeficient conditions

- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years
prior to randomization

- History of seizure disorder or unexplained blackouts OR history of a seizure within 6
months prior to Baseline

- History of suicidal ideation or an episode of clinically severe depression (as
determined by the Investigator) within 3 months prior to Day 1

- An MS relapse that has occurred within the 50 days prior to randomization AND/OR the
subject has not stabilized from a previous relapse prior to randomization

- Known history of, or positive screening test result for hepatitis C virus or
hepatitis B virus

- Varicella or herpes zoster virus infection or any severe viral infection within 6
weeks before screening

- Exposure to varicella zoster virus within 21 days before screening

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
We found this trial at
47
sites
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Ciudad Autónoma de Buenos Aires, Buenos Aires
?
mi
from
Ciudad Autónoma de Buenos Aires,
Click here to add this to my saved trials
Clinton Township, Michigan 48038
?
mi
from
Clinton Township, MI
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Kirkland, WA
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Latham, NY
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Winston Salem, North Carolina 27157
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials
Worchester, Massachusetts 01655
?
mi
from
Worchester, MA
Click here to add this to my saved trials