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 |
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Ciudad Autónoma de Buenos Aires, Buenos Aires
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials