A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

CompletadoFase 3ClinicalTrials.gov

ID: NCT00712933Tipo: INTERVENTIONALInicio: 30 de may de 2008Fin estimado: 9 de dic de 2016

Reumatología

Traducción no disponible, mostrando original

Resumen

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Descripción detallada

This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Criterios de exclusión

Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.

Intervenciones

drug

belimumab

Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Ubicaciones

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHuman Genome Sciences Inc., a GSK Company

ColaboradorGlaxoSmithKline

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