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NCT00583362 · ClinicalTrials.gov registry record · Phase 2
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
A Phase 2 study, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 298
- Enrollment target
NCT00583362: Completed Phase 2 study, sponsored by Human Genome Sciences Inc., a GSK Company.
NCT00583362 is a Phase 2 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 298 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583362, a Phase 2 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 298 participants
- Enrollment target
Study Summary
This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
Primary Outcome
An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example \[eg\], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization,
Interventions
- BIOLOGICAL Belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2005-05-04 |
| Est. Completion | 2016-02-23 |
| Phase | Phase 2 |
What the finished NCT00583362 record still lists
NCT00583362 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher).
The record links to 0 conditions, and to 1 intervention - of which Belimumab is the first listed.
NCT00583362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583362 about?
NCT00583362 is a clinical study titled "A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02". This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
What is the current status of trial NCT00583362?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 298 participants. The study started on 2005-05-04. Estimated completion is 2016-02-23.
What interventions are being tested in trial NCT00583362?
The interventions under investigation include: Belimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00583362?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583362's enrollment target sits among peer trials
298 188th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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