Estudio de fase 2 de dosis múltiples intravenosas de LY2127399 en pacientes con artritis reumatoide en tratamiento concomitante con metotrexato y respuesta inadecuada a la terapia con inhibidores del TNFα

CompletadoFase 2ClinicalTrials.gov

ID: NCT00689728Tipo: INTERVENTIONALInicio: 1 de jun de 2008Fin estimado: 1 de may de 2010

Resumen

El propósito de este estudio es explorar si LY2127399 es efectivo para aliviar los signos y síntomas de la artritis reumatoide (AR) en pacientes con antecedente de respuesta inadecuada o intolerancia a al menos un tratamiento con inhibidor del factor de necrosis tumoral alfa (TNFα). Ejemplos de estos tratamientos con inhibidores del TNFα actualmente disponibles en el mercado incluyen Enbrel® (etanercept), Remicade® (infliximab) y Humira® (adalimumab).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis
Active Rheumatoid Arthritis
Current, regular use of Methotrexate, at a stable dose
Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
Other criteria to be reviewed by study doctor

Criterios de exclusión

Use of excluded medications (reviewed by study doctor)
Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
Evidence of tuberculosis
Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
Other criteria to be reviewed by study doctor

Intervenciones

biological

LY2127399

LY2127399 will be administered as a single IV infusion over 30 minutes.

drug

Placebo

Placebo will be administered as a single IV infusion over 30 minutes.

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Caba, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Juan, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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