A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors
CompletadoFase 2ClinicalTrials.gov
ID: NCT02015520Tipo: INTERVENTIONALInicio: 1 de jun de 2012Fin estimado: 1 de jun de 2015
The primary purpose of this study is to identify an appropriate dose of study medication.
Elegibilidad
Edad mínima: 18 YearsSexo: ALL
Criterios de inclusión
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) \[1987\] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[2010\]) at least 16 weeks prior to screening
ACR global functional status class of 1 to 3
Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
Elevated High-sensitivity (hs) CRP and/or ESR
Criterios de exclusión
Active serious infection
History of or active tuberculosis (TB)
Elevated liver function tests (LFTs)
Intervenciones
drug
Clazakizumab
drug
Placebo (Matching with Clazakizumab)
Ubicaciones
Local Institution
Quilmes, Buenos Aires, Argentina
Local Institution
Buenos Aires, Argentina
Local Institution
Buenos Aires, Argentina
Local Institution
Córdoba, Argentina
Local Institution
San Miguel de Tucumán, Argentina
Patrocinadores
PrincipalCSL Behring
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