Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

CompletadoFase 2ClinicalTrials.gov

ID: NCT00785928Tipo: INTERVENTIONALInicio: 1 de oct de 2008Fin estimado: 1 de dic de 2010

Traducción no disponible, mostrando original

Resumen

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have given written informed consent
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis (RA)
Current, regular use of Methotrexate, at a stable dose
Other criteria to be reviewed by study doctor

Criterios de exclusión

Use of excluded medications(reviewed by study doctor)
Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Evidence of tuberculosis
Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
Other criteria to be reviewed by study doctor

Intervenciones

biological

LY2127399

Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

drug

Placebo

Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

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.

Quilmes, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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