An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

CompletadoFase 2ClinicalTrials.gov

ID: NCT01305746Tipo: INTERVENTIONALInicio: 1 de abr de 2011Fin estimado: 1 de oct de 2013

Reumatología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010

Criterios de exclusión

Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
Pregnant or nursing
Any prior administration of a B-cell modulating therapy other than A-623
Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods

Intervenciones

drug

A-623

High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

drug

A-623

Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

drug

A-623

High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Ubicaciones

Investigator Site 404

Caba, Buenos Aires, Argentina

Investigator Site 402

Caba, Buenos Aires, Argentina

Investigator Site 407

Caba, Buenos Aires, Argentina

Investigator Site 401

Caba, Buenos Aires, Argentina

Investigator Site 408

San Juan, San Juan Province, Argentina

Investigator Site 403

Rosario, Santa Fe Province, Argentina

Investigator Site 406

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalAnthera Pharmaceuticals

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