A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

TerminadoFase 3ClinicalTrials.gov

ID: NCT00430677Tipo: INTERVENTIONALInicio: 1 de jun de 2007Fin estimado: 1 de ago de 2011

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

Descripción detallada

Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
A stable serum creatinine ≤3 mg/dL

Criterios de exclusión

Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit
Subjects with drug-induced SLE, as opposed to idiopathic SLE
Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
Subjects who have received treatment with rituximab \< 6 months prior to the screening visit

Intervenciones

drug

Corticosteroids (prednisone or prednisolone)

tablets, oral, 0.5-0.8 mg/kg, daily

drug

Abatacept

intravenous solution, injectable, 30 mg/kg, every 28 days

drug

Abatacept

intravenous solution, injectable, 10 mg/kg, every 28 days

drug

Mycophenolate mofetil (MMF)

tablets, oral, 1.5 to 2 g, daily

drug

Abatacept

intravenous solution, injectable, 10 mg/kg, every 28 days

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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