Unknown

Dataset Information

0

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.


ABSTRACT: BACKGROUND:To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA). METHODS:In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4-17?years who failed ?1 biologic or methotrexate received weight-tiered (?100?kg: 1000?mg) intravenous abatacept at Weeks 0, 2, 4, and every 4?weeks thereafter. The study comprised a short-term period (16?weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions of patients achieving Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP) remission (score?

SUBMITTER: Hara R 

PROVIDER: S-EPMC6492394 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

altmetric image

Publications

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.

Hara Ryoki R   Umebayashi Hiroaki H   Takei Syuji S   Okamoto Nami N   Iwata Naomi N   Yamasaki Yuichi Y   Nakagishi Yasuo Y   Kizawa Toshitaka T   Kobayashi Ichiro I   Imagawa Tomoyuki T   Kinjo Noriko N   Amano Norihito N   Takahashi Yoko Y   Mori Masaaki M   Itoh Yasuhiko Y   Yokota Shumpei S  

Pediatric rheumatology online journal 20190430 1


<h4>Background</h4>To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA).<h4>Methods</h4>In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4-17 years who failed ≥1 biologic or methotrexate received weight-tiered (< 75 kg: 10 mg/kg; 75-100 kg: 750 mg; > 100 kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short  ...[more]

Similar Datasets

| S-EPMC6032847 | biostudies-literature
| S-EPMC8487314 | biostudies-literature
| S-EPMC5745974 | biostudies-literature
| S-EPMC8048692 | biostudies-literature
2009-04-13 | GSE15645 | GEO
| S-EPMC7036185 | biostudies-literature
| S-EPMC4216020 | biostudies-other
2009-04-13 | E-GEOD-15645 | biostudies-arrayexpress
| S-EPMC2727897 | biostudies-other
| S-EPMC4521899 | biostudies-other