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

NCT01064401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1841

Last updated 2016-07-11

Study results available
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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.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

BIOLOGICAL

BIIB019 (Daclizumab High Yield Process)

Daclizumab High Yield Process for subcutaneous injection

DRUG

Interferon beta-1a Placebo

Placebo to interferon beta-1a intramuscular injection

BIOLOGICAL

Interferon beta-1a

Interferon beta-1a for intramuscular injection

DRUG

Daclizumab High Yield Process Placebo

Placebo to Daclizumab High Yield Process subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-03-31
Completion
2014-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Sweden
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064401 on ClinicalTrials.gov