A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)

CompletadoFase 2ClinicalTrials.gov

ID: NCT02919475Tipo: INTERVENTIONALInicio: 14 de sept de 2016Fin estimado: 25 de jun de 2018

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

A diagnosis of RA prior to the Screening Visit.
Active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the Screening and Baseline Visits.
Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

Criterios de exclusión

Prior/current exposure to biologic and/or kinase inhibitor therapy.
Known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.
Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or hepatitis C (HCV) virus at the Screening Visit.
Positive drug of abuse and alcohol test results.
History of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to Day 1.

Intervenciones

drug

JTE-051

Active drug tablets containing JTE-051

drug

Placebo

Placebo tablets identical in appearance to the active drug tablets

Ubicaciones

La Plata, Buenos Aires, Argentina

San Fernando, Buenos Aires, Argentina

Barrio Norte, Córdoba Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Córdoba, Argentina

San Juan, Argentina

Patrocinadores

PrincipalAkros Pharma Inc.

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