Resumen

El propósito de este estudio es evaluar la eficacia de ustekinumab y CNTO 1959 en la reducción de los signos y síntomas de la enfermedad en pacientes con artritis reumatoide (AR) activa a pesar de la terapia concomitante con methotrexate (MTX), y evaluar la seguridad de ustekinumab y CNTO 1959 en esta población.

Descripción detallada

Este es un estudio aleatorizado (los pacientes son asignados al tratamiento por azar), doble ciego (el personal del estudio y los pacientes no sabrán qué tratamiento se está asignando), multicéntrico, controlado con placebo (un placebo es un tratamiento idéntico en apariencia al agente del estudio, pero que no contiene ningún ingrediente activo), de rango de dosis. Aproximadamente 250 pacientes serán asignados aleatoriamente a 1 de 5 grupos de tratamiento. La duración máxima de participación en el estudio es de 54 semanas, incluyendo un período de selección de 6 semanas. El fin del estudio será la última visita de seguimiento del último paciente. Se realizarán visitas y evaluaciones del estudio, y se monitoreará la seguridad de los pacientes a lo largo del estudio.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Have had RA for at least 6 months prior to screening
Have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
Have been treated with and tolerated MTX for at least 6 months prior to screening, and have a MTX dose of \>= 10 mg and \<= 25 mg per week and stable for at least 12 weeks prior to first administration of study agent
Have active RA, defined as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints at the time of screening and baseline; serum C-reactive protein (CRP) \>= 0.80 mg/dL at screening. The investigator may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single repeat testing during the screening period
If using oral corticosteroids, must be on a stable dose of \<= 10 mg/day of prednisone or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the first administration of study agent. If not using corticosteroids at Week 0, the patient must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics regularly for RA, the patient must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the patient must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent

Criterios de exclusión

Has other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study agent therapy
Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled
Has any known malignancy or history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly
Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or its inactive ingredients
Has ever received any approved or investigational biologic agent

Intervenciones

drug

Placebo + methotrexate (MTX) (Group 1)

Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

drug

Ustekinumab + MTX (Group 2)

Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

drug

Ustekinumab + MTX (Group 3)

Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)

drug

CNTO 1959 + MTX (Group 4)

CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

drug

CNTO 1959 + MTX (Group 5)

CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Placebo + methotrexate (MTX) (Group 1)

Ustekinumab + MTX (Group 2)

Ustekinumab + MTX (Group 3)

CNTO 1959 + MTX (Group 4)

CNTO 1959 + MTX (Group 5)

Ubicaciones

Patrocinadores