Phase 3
Completed N=219
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)
Active Polyarticular Juvenile Idiopathic Arthritis
Source: ClinicalTrials.gov NCT01844518 ↗
Enrolled (actual)
219
Serious AEs
11.0%
Results posted
Mar 2016
Primary outcomePrimary: Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 — 39.7 µg/mL
◆ Published Evidence
Emerging
19citations · ~3 / year
Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.
Summary
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
Linked Publications (5)
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Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.
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Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials.
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Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study.
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Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis.
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Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 |
39.7 | — |
| SECONDARY Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) |
83.2 | — |
| SECONDARY Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose |
29.5; 36.2; 33.0; 27.7; 42.5; 36.0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort |
0; 5; 1; 2; 102; 36 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period |
0; 0; 14; 5; 1; 2 | — |
| SECONDARY Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort |
3 | — |
| SECONDARY Number of Participants With Positive Immunogenicity Response in the Cumulative Period |
8; 7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01844518) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.