A Phase 3 Multi-center, Open-Label Study to Evaluate Phar... | EligiMed

A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01844518Tipo: INTERVENTIONALInicio: 30 de ago de 2013Fin estimado: 1 de feb de 2023

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.

Criterios de exclusión

Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
Subjects who have failed more than two TNFα antagonists or other biologic DMARDs

Intervenciones

biological

Abatacept

Ubicaciones

Local Institution - 0029

Rosario, Santa Fe Province, Argentina

Local Institution - 0028

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0030

Buenos Aires, Argentina

Local Institution - 0064

CABA, Argentina

Local Institution - 0031

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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