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COMPLETED Phase 4

Belimumab Assessment of Safety in SLE

NCT01705977 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL Placebo plus standard therapy
  • BIOLOGICAL Belimumab 10 mg/kg plus standard therapy
  • OTHER Standard therapy

Study Locations (20)

California

  • GSK Investigational Site — Covina
  • GSK Investigational Site — Huntington Beach
  • GSK Investigational Site — La Mesa
  • GSK Investigational Site — Long Beach
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Murrieta
  • GSK Investigational Site — Sacramento
  • GSK Investigational Site — San Leandro

Arizona

  • GSK Investigational Site — Glendale
  • GSK Investigational Site — Mesa
  • GSK Investigational Site — Phoenix
  • GSK Investigational Site — Phoenix

Alabama

  • GSK Investigational Site — Anniston
  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Huntsville

Florida

  • GSK Investigational Site — Clearwater
  • GSK Investigational Site — Hialeah
  • GSK Investigational Site — Tampa

Iowa

  • GSK Investigational Site — Cedar Rapids

Michigan

  • GSK Investigational Site — Saint Clair Shores

Trial Details

FieldValue
Enrollment Target 4,019 participants
Start Date 2012-11-27
Est. Completion 2022-08-10
Phase Phase 4

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01705977

The ClinicalTrials.gov registry entry for NCT01705977 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,019 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions — of which Placebo plus standard therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01705977 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01705977 about?

NCT01705977 is a clinical study titled "Belimumab Assessment of Safety in SLE". 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 commo...

What is the current status of trial NCT01705977?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,019 participants. The study started on 2012-11-27. Estimated completion is 2022-08-10.

What conditions does trial NCT01705977 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01705977?

The interventions under investigation include: Placebo plus standard therapy (BIOLOGICAL), Belimumab 10 mg/kg plus standard therapy (BIOLOGICAL), Standard therapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01705977?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01705977 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial