NCT01597492

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Human Genome Sciences Inc., a GSK Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-31
• Primary completion: 2015-09-01
• Completion: 2015-09-24
• First posted: 2012-05-14
• Last updated: 2018-08-16
• Results posted: 2016-07-25

Locations

15 sites across 1 country: United States