軸性脊椎関節炎の成人患者におけるウパダシチニブの有効性と安全性を評価する試験

基本情報

NCT ID

NCT04169373

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

734

治験依頼者名

AbbVie

概要

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). * To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). * To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib.

対象疾患

介入

依頼者（Sponsor）

実施施設 (16)