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)

Completed · Phase 3

Conditions studied: Active Polyarticular Juvenile Idiopathic Arthritis

In brief

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

Key facts

Study ID

NCT01844518

Run by

Bristol-Myers Squibb

People needed

219

Starts

2013-08-30

Expected to finish

2023-02-01

Last updated by the study team

2023-07-12

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution - 0003 — Little Rock, Arkansas, United States
• Local Institution - 0011 — Hartford, Connecticut, United States
• Local Institution - 0009 — Chicago, Illinois, United States
• Riley Hospital For Children — Indianapolis, Indiana, United States
• University Of Kansas Medical Center — Kansas City, Kansas, United States
• Local Institution - 0001 — Kansas City, Missouri, United States
• Local Institution - 0002 — The Bronx, New York, United States
• Local Institution - 0008 — Cincinnati, Ohio, United States
• Local Institution - 0005 — Portland, Oregon, United States
• Local Institution - 0004 — Salt Lake City, Utah, United States
• Seattle Children'S Hospital — Seattle, Washington, United States
• 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
• Local Institution - 0037 — Brussels, Belgium
• Local Institution - 0036 — Ghent, Belgium
• Local Institution - 0049 — Leuven, Belgium
• Local Institution — Curitiba, Paraná, Brazil
• Local Institution - 0038 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0042 — São Paulo, Brazil
• Local Institution - 0040 — São Paulo, Brazil
• Local Institution - 0041 — São Paulo, Brazil
• Local Institution - 0007 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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