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Belimumab Assessment of Safety in SLE

NCT01705977 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4019

Last updated 2024-07-15

Study results available
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Summary

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

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

OTHER

Standard therapy

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

Sponsors & Collaborators

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
2012-11-27
Primary Completion
2018-07-30
Completion
2022-08-10

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • Hong Kong
  • Hungary
  • Indonesia
  • Italy
  • Lithuania
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Ukraine

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 NCT01705977 on ClinicalTrials.gov