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)
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 2 - 17 |
Updated: | 2/17/2018 |
Start Date: | June 28, 2013 |
End Date: | December 29, 2023 |
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)
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)
at Day 113 in children and adolescents with pJIA
at Day 113 in children and adolescents with pJIA
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
13
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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University of Utah Research is a major component in the life of the U benefiting...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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