A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00424476Tipo: INTERVENTIONALInicio: 1 de may de 2007Fin estimado: 1 de mar de 2010

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Clinical diagnosis of SLE by ACR criteria.
Active SLE disease.
Autoantibody-positive.
On stable SLE treatment regimen.

Criterios de exclusión

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.

Intervenciones

drug

Placebo

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.

drug

Belimumab 1 mg/kg

Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

drug

Belimumab 10 mg/kg

Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Ubicaciones

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

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalHuman Genome Sciences Inc.

ColaboradorGlaxoSmithKline

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