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NCT02119156 · ClinicalTrials.gov registry record · Phase 3

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

A Phase 3 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
80
Enrollment target
20
Study locations

NCT02119156 is a Phase 3 study of Systemic Lupus Erythematosus that has completed, run by GlaxoSmithKline. The registered enrollment target is 80 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02119156, a Phase 3 study of Systemic Lupus Erythematosus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
80 participants
Enrollment target
20
Study locations

Study Summary

This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • DRUG Belimumab

Study Locations (20)

Other

  • GSK Investigational Site - Beijing
  • GSK Investigational Site - Beijing
  • GSK Investigational Site - Chiba
  • GSK Investigational Site - Ehime
  • GSK Investigational Site - Hokkaido
  • GSK Investigational Site - Miyagi
  • GSK Investigational Site - Nagasaki
  • GSK Investigational Site - Tokyo
  • GSK Investigational Site - Tokyo
  • GSK Investigational Site - Daegu
  • GSK Investigational Site - Seoul
  • GSK Investigational Site - Seoul
  • GSK Investigational Site - Seoul
  • GSK Investigational Site - Suwon, Kyonggi-do

California

  • GSK Investigational Site - Los Angeles

New York

  • GSK Investigational Site - Manhasset

Texas

  • GSK Investigational Site - Dallas

Anhui

  • GSK Investigational Site - Hefei

Jiangsu

  • GSK Investigational Site - Suzhou

Zhejiang

  • GSK Investigational Site - Hangzhou

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2014-05-13
Est. Completion 2018-12-14
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02119156

The ClinicalTrials.gov registry entry for NCT02119156 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Belimumab is the first listed.

NCT02119156 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT02119156 about?

NCT02119156 is a clinical study titled "Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients". This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanentl...

What is the current status of trial NCT02119156?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2014-05-13. Estimated completion is 2018-12-14.

What conditions does trial NCT02119156 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT02119156?

The interventions under investigation include: Belimumab (DRUG).

Who is sponsoring clinical trial NCT02119156?

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

Where is trial NCT02119156 being conducted?

This trial has 20 study locations across California, New York, Texas, Anhui, Jiangsu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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