Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220565

Enrollment

Registered

2008-06-10

Start date

2008-06-10

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 Rheumatoid Arthritis (JRA)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who have a diagnosis of Polyarticular JRA by the ACR criteria.

Exclusion criteria

Exclusion criteria: Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Design outcomes

Primary

Measure	Time frame
ACR Pediatric 30 response rate	—

Secondary

Measure	Time frame
ACR Pediatric 50 response rate, ACR Pediatric 70 response rate, adverse event including vital signs and clinical laboratory test, serum adalimumab and anti-adallimumab antibody level	—

Outcome results

None listed

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