巨細胞性動脈炎患者におけるウパダシチニブの安全性と有効性を評価する試験

基本情報

NCT ID

NCT03725202

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

438

治験依頼者名

AbbVie

概要

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1. Safety and efficacy data through 06 February 2024 are included in the interim analysis, which was conducted after all participants completed the Week 52 visit or discontinued from the study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)