A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT02376790Tipo: INTERVENTIONALInicio: 3 de mar de 2015Fin estimado: 6 de jul de 2018

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

Descripción detallada

The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period. At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
Subject has an active psoriatic skin lesion
Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
Subject has no prior use of methotrexate for PsA.
Subject has no history of tuberculosis
Subject has a negative test for tuberculosis, hepatitis B and C.

Criterios de exclusión

Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.

Intervenciones

drug

Etanercept

Etanercept was administered by subcutaneous injection once a week

drug

Methotrexate

Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.

drug

Placebo to Etanercept

Placebo to etanercept was administered by subcutaneous injection once a week.

drug

Placebo to Methotrexate

Placebo to methotrexate capsules taken orally once a week.

Ubicaciones

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAmgen

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