Resumen

El objetivo principal de este estudio es determinar si LY2127399 es seguro y eficaz para el tratamiento de la artritis reumatoide en combinación con metotrexato como tratamiento de base. El estudio comprende 3 períodos: Período 1: 52 semanas de tratamiento enmascarado Período 2: 48 semanas adicionales de tratamiento abierto Período 3: 48 semanas de seguimiento post-tratamiento

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
At least 8 tender and swollen joints
At least one erosion of a hand or foot joint observed on an X-ray
An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
Woman must not be pregnant, breastfeeding, or become pregnant during the study

Criterios de exclusión

Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
Steroid injection or intravenous (iv) infusion in the last 6 weeks
Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
History of a serious reaction to other biological DMARDs
History of the use of rituximab or other B cell therapy
Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
Hepatitis or human immunodeficiency virus (HIV)
A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
Symptoms of herpes zoster or herpes simplex within the last month
Active or latent tuberculosis (TB)
Current symptoms of a serious disorder or illness
Use of an investigational drug within the last month
History of the use of rituximab, any other B cell targeted biotherapy, or denosumab

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.

Córdoba, 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.

Luján, 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.

Mar del Plata, 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

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

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de LY2127399 en pacientes con artritis reumatoide moderada a grave que presentaron respuesta inadecuada al tratamiento con metotrexato (FLEX M)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

LY2127399

Placebo Q2W

Placebo Q4W

Methotrexate

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.

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.

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.

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.

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.

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.

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.

Patrocinadores