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NCT01597492 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 4 study of Systemic Lupus Erythematosus, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
- 15
- Study locations
NCT01597492: Completed Phase 4 study of Systemic Lupus Erythematosus, sponsored by Human Genome Sciences Inc., a GSK Company.
NCT01597492 is a Phase 4 study of Systemic Lupus Erythematosus that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 79 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597492, a Phase 4 study of Systemic Lupus Erythematosus, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
Primary Outcome
A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level \>=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late co
Conditions Studied
Interventions
- BIOLOGICAL Belimumab plus Early Vaccination
- BIOLOGICAL Belimumab plus Late Vaccination
Study Locations (15)
Maryland
- GSK Investigational Site - Baltimore
- GSK Investigational Site - Cumberland
- GSK Investigational Site - Hagerstown
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Austin
- GSK Investigational Site - Houston
Washington
- GSK Investigational Site - Seattle
- GSK Investigational Site - Spokane
Alabama
- GSK Investigational Site - Birmingham
Arizona
- GSK Investigational Site - Paradise Valley
Louisiana
- GSK Investigational Site - Shreveport
New York
- GSK Investigational Site - New York
Ohio
- GSK Investigational Site - Toledo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2012-05-31 |
| Est. Completion | 2015-09-24 |
| Phase | Phase 4 |
What the finished NCT01597492 record still lists
NCT01597492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 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 2 interventions - of which Belimumab plus Early Vaccination is the first listed.
NCT01597492 lists 15 locations in 10 states (Maryland, Texas, Washington).
Frequently Asked Questions
What is clinical trial NCT01597492 about?
NCT01597492 is a clinical study titled "A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)". The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
What is the current status of trial NCT01597492?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2012-05-31. Estimated completion is 2015-09-24.
What conditions does trial NCT01597492 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT01597492?
The interventions under investigation include: Belimumab plus Early Vaccination (BIOLOGICAL), Belimumab plus Late Vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT01597492?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01597492 being conducted?
This trial has 15 study locations across Alabama, Arizona, Louisiana, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01597492's enrollment target sits among peer trials
79 63rd of 99 higher than 37 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.
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