The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
865
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
SLE Responder Index (SRI) Response Rate at Week 52
Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).
Time frame: Baseline, 52 weeks
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
Time frame: Baseline, 52 weeks
Mean Change in Physician's Global Assessment (PGA) at Wk 24.
The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time frame: Baseline, 24 weeks
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.
The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Time frame: Baseline, 24 weeks
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
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OMI, Organización Médica de Investigación
Buenos Aires, Argentina
CIER, Centro de Investigaciones en Enfermedades Reumáticas
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Hospital General de Agudos Carlos G. Durand
Buenos Aires, Argentina
Centro Privado de Medicina Familiar
Buenos Aires, Argentina
Hospital Sirio Libanes
Buenos Aires, Argentina
Atencion Integral en Reumatologia
Buenos Aires, Argentina
Instituto de Investigaciones Medicas
Buenos Aires, Argentina
Hospital Interzonal General San Martín
La Plata, Argentina
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
Rosario, Argentina
...and 82 more locations
Time frame: Baseline, Weeks 40 through 52