A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT01162681Tipo: INTERVENTIONALInicio: 1 de jul de 2010Fin estimado: 1 de abr de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of SLE by American College of Rheumatology guidelines.
On stable SLE treatment
Active SLE disease
Serologically active
years of age or older
Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Criterios de exclusión

Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
Liver disease.
Anemia, neutropenia, or thrombocytopenia.
Malignancy within past 5 years
Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
History of active tuberculosis or a history of tuberculosis infection.
Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
Prior administration of any B cell depleting therapy in the past 18 months.
Pregnant or nursing
History of congenital immunodeficiency

Intervenciones

drug

A-623

High dose given subcutaneously once a week for up to 52 weeks

drug

A-623

Low dose given subcutaneously once a week for up to 52 weeks

drug

A-623

High dose given subcutaneously once every 4 weeks for up to 52 weeks

other

Placebo Comparator

Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Ubicaciones

Investigator Site 404

Caba, Buenos Aires, Argentina

Investigator Site 402

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

Investigator Site 407

Buenos Aires, Argentina

Investigator Site 401

Buenos Aires, Argentina

Patrocinadores

PrincipalAnthera Pharmaceuticals

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