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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

NCT01639339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2021-03-19

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

Conditions

Interventions

BIOLOGICAL

Placebo plus standard therapy

Placebo plus standard therapy

BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10 mg/kg plus standard therapy

DRUG

Standard therapy

The standard therapies allowed in this study are: \- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR \- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Human Genome Sciences Inc., a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-12
Primary Completion
2019-07-25
Completion
2020-03-12

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Mexico
  • Netherlands
  • Philippines
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Entities

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 NCT01639339 on ClinicalTrials.gov