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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: Completed Phase 3 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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 Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Primary Outcome
SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to \>12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 v
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-05-13 |
| Est. Completion | 2018-12-14 |
| Phase | Phase 3 |
What the finished NCT02119156 record still lists
NCT02119156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower).
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 names 20 study sites across 7 states, led by 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.
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 NCT02119156's enrollment target sits among peer trials
80 61st of 99 higher than 38 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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