A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT00089804Tipo: INTERVENTIONALInicio: 1 de oct de 2004Fin estimado: 1 de feb de 2009

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Diagnosis of Systemic Lupus Erythematosus (SLE)
Active SLE renal disease within past 4 years.
Males or females between 12 and 70 years old.
Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
Ability to have weekly intravenous (IV) administration of study treatment.

Criterios de exclusión

Active SLE renal disease within past 3 months prior to entering study.
Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
Use of rituximab within 6 months prior to entering study.
Current abuse of drugs or alcohol.

Intervenciones

drug

abetimus sodium (LJP 394) and/or placebo solution

300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks

drug

abetimus sodium (LJP 394)

900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.

drug

Phosphate-buffered saline

A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks

Ubicaciones

CIR Hospital Sirio Libanes. Campana 4658

Buenos Aires, Ciudad Autonma de, Argentina

Instituto CAICI

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Organización Médica de la Investigación

Buenos Aires, Uruguay 725 P.B., Argentina

Unidad de Alergia, Asma e Inmunología Clínica

Buenos Aires, Argentina

Centro de Investigaciones en Enfermedades Reumaticas (CIER)

Buenos Aires, Argentina

Centro de Investigaciones Reumatologicas y Osteologicas

Buenos Aires, Argentina

Investigación Clínica Polivalente

La Plata, Argentina

Patrocinadores

PrincipalLa Jolla Pharmaceutical Company

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