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
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Ciudad Autónoma de Buenos Aires, Buenos Aires
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