Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan.

A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222073

Enrollment

Registered

2013-05-07

Start date

2013-09-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis.

Interventions

investigational material(s) Generic name etc : Abatacept INN of investigational material : Abatacept Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion 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 MTX. -Diagnosis of JIA by ILAR criteria as oligoarticular, polyarticular (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 or more than 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 or more than 2 joints with LOM at screening and at Week 0 (Day 1). The same joint can separately meet the definition of an active joint and a joint with LOM.

Exclusion criteria

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.).

Design outcomes

Primary

Measure	Time frame
efficacy ACR Pediatric 30 response rate. ACR Pediatric 30 response rate at Week 16 ACR pediatric 30 response is defined as 30 or more than 30% and improvement and 3 or more than 3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set and 30 or more than 30% worsening in not more than 1 of the 6 JIA core set variables	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics pharmacogenomics ACR pediatric 50 70 and 90 response rates. Inactive desease rate. CHAQ. Adverse Events, deaths, Serious Adverse Events, and AEs of special interest. Cmax and Ctrough of Abatacept. Immunogenicity positive rates. ACR pediatric 50, 70 and 90 response rates at Week 16. Disability index of the CHAQ at Week 16. Safety summarized by proportion of subjects with Adverse Events, deaths, Serious Adverse Events, and AEs of special interest in the ST period. Cmax of Abatacept in the ST period. Ctrough of Abatacept in the ST period. Immunogenicity positive rates in theST period.	—

Measure

Time frame

safety efficacy pharmacokinetics pharmacogenomics ACR pediatric 50 70 and 90 response rates. Inactive desease rate. CHAQ. Adverse Events, deaths, Serious Adverse Events, and AEs of special interest. Cmax and Ctrough of Abatacept. Immunogenicity positive rates. ACR pediatric 50, 70 and 90 response rates at Week 16. Disability index of the CHAQ at Week 16. Safety summarized by proportion of subjects with Adverse Events, deaths, Serious Adverse Events, and AEs of special interest in the ST period. Cmax of Abatacept in the ST period. Ctrough of Abatacept in the ST period. Immunogenicity positive rates in theST period.

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026