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COMPLETED Phase 4

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

NCT01597492 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 79 participants
Start Date 2012-05-31
Est. Completion 2015-09-24
Phase Phase 4

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences Inc., a GSK Company, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01597492 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Maryland, Texas, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01597492?

The interventions under investigation include: Belimumab plus Early Vaccination (BIOLOGICAL), Belimumab plus Late Vaccination (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01597492?

This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial