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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

NCT00410384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 819

Last updated 2017-02-01

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Conditions

Interventions

DRUG

Placebo

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

DRUG

Belimumab 1 mg/kg

Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

DRUG

Belimumab 10 mg/kg

Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Human Genome Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · Human Genome Sciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Costa Rica
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00410384 on ClinicalTrials.gov