MedTrace Logo

Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis

NCT00390221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2016-07-11

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

BIOLOGICAL

BIIB019 (Daclizumab High Yield Process)

SC injection

DRUG

Placebo

Placebo SC 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
2008-02-29
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • Czechia
  • Germany
  • Hungary
  • India
  • Poland
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00390221 on ClinicalTrials.gov