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Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:
An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects

Clinical Trial Summary

This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

Clinical Trial Description

This study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02119156
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date May 13, 2014
Completion date December 14, 2018
View Details
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