A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

CompletadoFase 2ClinicalTrials.gov

ID: NCT01972568Tipo: INTERVENTIONALInicio: 1 de dic de 2013Fin estimado: 1 de sept de 2016

Traducción no disponible, mostrando original

Resumen

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eligible male and female subjects, aged 18 years or older
Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to \[\>=\] 6 at screening visit
At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed \>= 6 months prior to the screening visit)
Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies

Criterios de exclusión

Subjects have demyelinating disorder
Severe central nervous system SLE
Use of cyclophosphamide within 3 months of the screening visit
Urine protein:creatinine ratio (UPCr) \>= 2 milligram per milligram (mg/mg) per day

Intervenciones

drug

Atacicept 75 milligram (mg)

Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

drug

Atacicept 150 mg

Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.

drug

Placebo

Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.

Ubicaciones

APRILLUS

Ciudad Autonoma Buenos Aires, Argentina

Atencion Integral en Reumatologia (AIR)

Ciudad Autonoma Buenos Aires, Argentina

Hospital Italiano

Ciudad Autonoma Buenos Aires, Argentina

Organizacion Medica de Investigacion (OMI)

Ciudad Autonoma Buenos Aires, Argentina

Policlìnica Red Omip S.A - Ensayos Clinicos GC

Mar del Plata, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Cordis S.A.

Salta, Argentina

Centro Polivalente de Asistencia e Inv. Clinica CER

San Juan, Argentina

Centro Integral de Reumatologia

San Miguel de Tucumán, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEMD Serono

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