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COMPLETEDPHASE3

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

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

NCT01064401•Biogen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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

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
+4 more criteria

Locations (228)

Research Site

Gilbert, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

La Jolla, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Naples, Florida, United States

Research Site

Pompano Beach, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Sunrise, Florida, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

March 1, 2014

Completion Date

July 1, 2014

Last Updated

July 11, 2016

Enrollment

1,841

ACTUAL participants

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

BIIB019 (Daclizumab High Yield Process)

BIOLOGICAL

Interferon beta-1a Placebo

DRUG

Interferon beta-1a

BIOLOGICAL

Daclizumab High Yield Process Placebo

DRUG

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831

Multiple SclerosisRelapsing-remitting Multiple Sclerosis

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RECRUITING

Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

NCT06586177

Relapsing-remitting Multiple Sclerosis

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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