MedTrace Logo

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

NCT01632241 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2021-09-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

Conditions

Interventions

BIOLOGICAL

Placebo plus standard therapy

Placebo plus standard therapy

BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10mg/kg plus standard therapy

DRUG

Standard therapy

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

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
2013-02-19
Primary Completion
2018-06-18
Completion
2019-01-28

Countries

  • United States
  • Brazil
  • Colombia
  • France
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

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 NCT01632241 on ClinicalTrials.gov