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NCT01705977 · ClinicalTrials.gov registry record · Phase 4

Belimumab Assessment of Safety in SLE

A Phase 4 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
4,019
Enrollment target
20
Study locations

NCT01705977: Completed Phase 4 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

NCT01705977 is a Phase 4 study of Systemic Lupus Erythematosus that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,019 participants, above the 340-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (1082% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01705977, a Phase 4 study of Systemic Lupus Erythematosus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
4,019 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than \[\>\]50 percent \[%\]) of the time. The on-treatment period was the primary analysis period for safety analyses.

Conditions Studied

Systemic Lupus Erythematosus

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
GlaxoSmithKline

1,345 total trials

What the finished NCT01705977 record still lists

NCT01705977 is an interventional study that assigns participants to a tested intervention. Its 4,019 participants enrollment target places it among the larger protocols in the corpus, above the 340-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (1082% higher).

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.

NCT01705977 names 20 study sites across 6 states, led by California, Arizona, Alabama.

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.

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).

Who is sponsoring clinical trial NCT01705977?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Systemic Lupus Erythematosus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01705977's enrollment target sits among peer trials

4,019 3rd of 99 higher than 97 of 99 other Systemic Lupus Erythematosus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01705977, the US trial registry maintained by the National Library of Medicine. NCT01705977 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.