Phase 2
Completed N=449
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT00071487 ↗
Enrolled (actual)
449
Serious AEs
13.7%
Results posted
Aug 2012
Primary outcomePrimary: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. — -17.2; -23.3; -11.3; -23.7 percent change — p=0.3677
Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. |
-17.2; -23.3; -11.3; -23.7 | 0.3677 |
| PRIMARY Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) |
83; 68; 61; 70 | 0.6423 |
| SECONDARY Percentage Change From Baseline in SELENA SLEDAI Score at Week 52 |
-20.6; -29.7; -23.9; -27.9 | 0.1763 |
| SECONDARY Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52 |
317.3; 288.7; 320.3; 286.9 | 0.1287 |
| SECONDARY Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52 |
-19.1; -20.8; -26.5; -22.0 | 0.7823 |
| SECONDARY Area Under the Curve (AUC) of BILAG Score at Week 52 |
315.4; 310.6; 300.4; 302.7 | 0.7822 |
| SECONDARY Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks |
78; 63; 84; 62 | 0.5615 |
| SECONDARY Percentage of Patients With a Reduction in Prednisone Dose |
27.1; 20.0; 31.4; 44.7 | 0.4355 |
Eligibility Criteria
Primary Inclusion Criteria
- Clinical diagnosis of SLE
- "Active" SLE disease
- On a stable SLE treatment regimen
- History of measurable autoantibodies
Primary Exclusion Criteria
- Received a non-FDA approved investigational agent within last 28 days
- Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
- Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
- Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
- History of renal transplant
- History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
- History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
- Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Data sourced from ClinicalTrials.gov (NCT00071487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.