A Phase 3 Randomized, Double-Blind, Placebo-Controlled St... | EligiMed

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis

TerminadoFase 3ClinicalTrials.gov

ID: NCT01714817Tipo: INTERVENTIONALInicio: 22 de ene de 2013Fin estimado: 30 de may de 2018

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Note: Subjects \> 16 are eligible for enrollment at selected centers
Potential subjects must have active lupus nephritis
Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:
Worsening of lupus nephritis OR
UPCR ≥ 3 at Screening OR
Active urine sediment OR
Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis
Signed Written Informed Consent
Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment

Criterios de exclusión

Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible

Intervenciones

biological

BMS-188667

drug

Mycophenolate mofetil

drug

Prednisone

biological

Placebo matching with BMS-188667

Ubicaciones

Organizacion Medica De Investigacion S.A. (Omi)

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Hospital Privado-Centro Medico De Cordoba S.A.

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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