A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus
GlaxoSmithKline
Summary
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented diagnosis of systemic lupus erythematosus (SLE) within 2 years of signing the informed consent according to the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria 2019 * Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer greater than or equal to (≥) 1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test from 2 independent time points * Active SLE defined as: * Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) sc…
Interventions
- DrugBelimumab (GSK1550188)
GSK1550188 will be administered subcutaneously.
Locations (113)
- GSK Investigational SiteAnniston, Alabama
- GSK Investigational SiteFlagstaff, Arizona
- GSK Investigational SiteMesa, Arizona
- GSK Investigational SiteTucson, Arizona
- GSK Investigational SiteCovina, California
- GSK Investigational SiteFontana, California