At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity
In Brief
A Phase 4 clinical trial evaluating Belimumab and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 231 participants across 1 site.
Detailed Summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.
Study Details
Timeline
Interventions
Belimumab 2mg/kg intravenously
Placebo intravenously