Phase 3
Completed N=20
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
Source: ClinicalTrials.gov NCT01835470 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16 — 90.0 percentage of participants
◆ Published Evidence
Emerging
14citations · ~2 / year
Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.
Summary
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics
Linked Publications
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Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16 |
90.0 | — |
| SECONDARY Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 |
75.0; 70.0; 35.0; 25.0 | — |
| SECONDARY Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16 |
43.18 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period |
0; 2; 1; 0; 5; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period |
163.13; 172.43; 167.85 | — |
| SECONDARY Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period |
25.50; 38.64; 17.24; 16.79; 15.56 | — |
| SECONDARY Number of Participants With Positive Immunogenicity During the Short Term Period |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or Methotrexate (MTX).
- Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.
- Men and women, ages 4 to 17 years, inclusive at enrollment.
- Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:
- ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening and at Week 0 (Day 1).
- ≥2 joints with LOM at screening and at Week 0 (Day 1).
Exclusion Criteria
- Systemic onset JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
- Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)
Data sourced from ClinicalTrials.gov (NCT01835470) 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.