A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) – SELECT – PsA 2

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 642 人开始时间: 2017年7月19日最近更新: 2022年4月25日

适应症

试验速览

暂无简介。

•1. Male or female, at least 18 years of age
•2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
•3. Subject has active disease at Baseline defined as = 3 tender joints (based on 68 joint counts) and = 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
•4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
•5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 518
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 124

•1. Prior exposure to any Janus Kinase (JAK) inhibitor
•2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.

发起方