Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de CNTO6785 en participantes con artritis reumatoide (AR) activa a pesar del tratamiento con metotrexato (MTX).

Descripción detallada

Este es un estudio aleatorizado (los participantes son asignados al tratamiento por azar), doble ciego (los participantes y el personal del estudio no sabrán qué tratamientos se están administrando), controlado con placebo (un placebo tiene una apariencia idéntica al medicamento en estudio pero no contiene ingredientes activos), multicéntrico. El estudio constará de 3 fases: una fase de selección, una fase de tratamiento y una fase de seguimiento. Aproximadamente 250 participantes con AR activa a pesar del tratamiento con MTX serán asignados aleatoriamente para recibir placebo o CNTO 6785 durante la fase de tratamiento doble ciego. El período máximo de tratamiento activo será de 28 semanas. La duración máxima de participación en el estudio será de 44 semanas. La seguridad de los participantes será monitoreada durante todo el estudio.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Criterios de exclusión

Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
Has a diagnosis of fibromyalgia
Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
At screening, the results of laboratory tests must meet protocol-specified criteria
Has ever received any approved or investigational biologic agent for a rheumatic indication

Intervenciones

drug

Placebo

Placebo subcutaneous injections (SC) every 4 weeks through Week 12

drug

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28

drug

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks through Week 28

drug

CNTO 6785 100 mg

CNTO 6785 100 mg SC every 4 weeks through Week 28

drug

CNTO 6785 50 mg

CNTO 6785 50 mg SC every 4 weeks through Week 28

drug

CNTO 6785 15 mg

CNTO 6785 15 mg SC every 4 weeks through Week 28

drug

Methotrexate (MTX)

MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase 2, de determinación de dosis para evaluar la eficacia y seguridad de CNTO 6785 en sujetos con artritis reumatoide activa a pesar del tratamiento con metotrexato

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Placebo

CNTO 6785 200 mg

CNTO 6785 200 mg

CNTO 6785 100 mg

CNTO 6785 50 mg

CNTO 6785 15 mg

Methotrexate (MTX)

Ubicaciones

Patrocinadores