A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

CompletadoFase 2ClinicalTrials.gov

ID: NCT01405196Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de mar de 2014

Traducción no disponible, mostrando original

Resumen

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male or female subjects between ages of 18 and 75 years old at time of signing consent.
Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
Have a unequivocally positive anti-nuclear antibody (ANA) test result.
Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Criterios de exclusión

Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.

Intervenciones

biological

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

biological

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

biological

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

biological

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16

Ubicaciones

Framingham Centro Medico

La Plata, Buenos Aires, Argentina

Instituto CAICI S.R.L.

Rosario, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC

C.a.b.a, Argentina

Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan

San Juan, Argentina

Patrocinadores

PrincipalPfizer

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