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COMPLETEDPHASE4

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

A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

NCT01597492•Human Genome Sciences Inc., a GSK Company

View on ClinicalTrials.gov

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).

Detailed Description

All patients in this study will receive belimumab plus standard therapy for SLE and vaccination against pneumococcus. Patients will be randomized to receive pneumococcal vaccination either 4 weeks prior (early vaccination group) or 24 weeks after (late vaccination group) their first belimumab dose. Vaccine response will be assessed 4 weeks after vaccine administration.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
•Active SLE disease.
•Autoantibody-positive.
•Have antibodies with titers \>1.0 microgram (mcg)/mL to no more than 9 of the 23 serotypes present in the pneumococcal vaccine.
•Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Exclusion Criteria

•Pregnant or nursing.
•Have received any prior treatment with belimumab.
•Have received a live vaccine within the past 30 days.
•Have received a pneumococcal vaccination with the past 5 years.
•Have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and CT scans), or biological medicines.
•Have required management of an infection or have had infections that keep coming back within the past 60 days.
•Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HB surface antigen (HBsAg) and anti-HB core antibody (anti-HBc):
•* Subjects positive for HBsAg are excluded.
•* Subjects negative for HBsAg but positive for anti-HBc, regardless of anti-HBs antibody status, are excluded.
•Hepatitis C: Positive test for Hepatitis C antibody.
+4 more criteria

Locations (15)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Paradise Valley, Arizona, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Cumberland, Maryland, United States

GSK Investigational Site

Hagerstown, Maryland, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Toledo, Ohio, United States

GSK Investigational Site

Duncansville, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

May 31, 2012

Primary Completion Date

September 1, 2015

Completion Date

September 24, 2015

Last Updated

August 16, 2018

Enrollment

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Belimumab plus Early Vaccination

BIOLOGICAL

Belimumab plus Late Vaccination

BIOLOGICAL

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

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Systemic Lupus Erythematosus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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