drugset / Trial / NCT02119156

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

NCT02119156

Phase 3 Completed 80 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

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 Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

Timeline

Start
2014-05-13
Primary completion
2018-12-14
Completion
2018-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg Intravenous