A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Phase 3

Completed

Interventions: Drug: Belimumab 10 mg/kg
Drug: Placebo
Drug: Belimumab 1 mg/kg

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Key

Exclusion Criteria

Pregnant or nursing
Have received treatment with any B cell targeted therapy.
Have received treatment with a biological investigational agent in the past year.
Have received IV cyclophosphamide within 180 days of Day 0.
Have severe lupus kidney disease.
Have active central nervous system (CNS) lupus.
Have required management of acute or chronic infections within the past 60 days.
Have current drug or alcohol abuse or dependence.
Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI) Response Rate at Week 52	Baseline, 52 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Physician's Global Assessment (PGA) at Wk 24.	Baseline, 24 weeks	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.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52	Baseline, Weeks 40 through 52
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.	Baseline, 52 weeks
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.	Baseline, 24 weeks	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.

Locations (92): Hospital Britanico de Buenos Aires
🇦🇷
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
OMI, Organización Médica de Investigación
🇦🇷
Ciudad Autonoma de Buenos Aires, Argentina
CIER, Centro de Investigaciones en Enfermedades Reumáticas
🇦🇷
Ciudad Autonoma de Buenos Aires, Argentina
Hospital General de Agudos Carlos G. Durand
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Ciudad Autonoma de Buenos Aires, Argentina
Hospital Interzonal General San Martín
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La Plata, Argentina
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
🇦🇷
Rosario, Argentina
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Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina