A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

CompletadoFase 2ClinicalTrials.gov

ID: NCT00650767Tipo: INTERVENTIONALInicio: 1 de mar de 2008Fin estimado: 1 de jul de 2009

Traducción no disponible, mostrando original

Resumen

This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
No prior use of biological agents for the treatment of rheumatoid arthritis.
Additional criteria exist.

Criterios de exclusión

Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
Additional criteria exist.

Intervenciones

drug

ARRY-438162, MEK inhibitor; oral

multiple dose, single schedule

drug

Placebo; oral

matching placebo

Ubicaciones

Asistencia Integral en Reumatologia

Buenos Aires, Argentina

CEMIC

Buenos Aires, Argentina

Hospital Britanico

Buenos Aires, Argentina

CER San Juan

San Juan, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Centro de Investigaciones Clinicas del Litoral SRL

Santa Fe, Argentina

Patrocinadores

PrincipalArray Biopharma, now a wholly owned subsidiary of Pfizer

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