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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01597492
The ClinicalTrials.gov registry entry for NCT01597492 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 79 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 Human Genome Sciences Inc., a GSK Company, which has 9 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 2 interventions - of which Belimumab plus Early Vaccination is the first listed.
NCT01597492 reports 15 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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