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

PHASE4CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

September 1, 2015

Study Completion Date

September 24, 2015

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Belimumab plus Early Vaccination

Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Pneumococcal vaccination is administered 4 weeks prior to the first dose of belimumab.

BIOLOGICAL

Belimumab plus Late Vaccination

Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Pneumococcal vaccination is administered 24 weeks after the first dose of belimumab.

Trial Locations (15)

10016

GSK Investigational Site, New York

16635

GSK Investigational Site, Duncansville

21201

GSK Investigational Site, Baltimore

21502

GSK Investigational Site, Cumberland

21740

GSK Investigational Site, Hagerstown

35249

GSK Investigational Site, Birmingham

43623

GSK Investigational Site, Toledo

71103

GSK Investigational Site, Shreveport

77090

GSK Investigational Site, Houston

78731

GSK Investigational Site, Austin

78758

GSK Investigational Site, Austin

85253

GSK Investigational Site, Paradise Valley

98133

GSK Investigational Site, Seattle

99204

GSK Investigational Site, Spokane

05401

GSK Investigational Site, Burlington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc., a GSK Company

INDUSTRY

NCT01597492 - A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) | Biotech Hunter | Biotech Hunter