EUCTR2016-004152-30-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic DrugModerately to Severely Active Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2016-004130-24-CZAbbVie Deutschland GmbH & Co. KG1,705
进行中（未招募）
1 期
A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic DrugModerately to Severely Active Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-004130-24-DEAbbVie Deutschland GmbH & Co. KG1,705
进行中（未招募）
1 期
A Study Comparing ABT-494 to Placebo in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic DrugEUCTR2016-004152-30-BEAbbVie Deutschland GmbH & Co. KG642
进行中（未招募）
1 期
A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic DrugModerately to Severely Active Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-004130-24-BEAbbVie Deutschland GmbH & Co. KG1,705
进行中（未招募）
1 期
A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD)Therapy (KEEPsAKE 1)Psoriatic Arthritis.MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2017-002465-22-GRAbbVie Deutschland GmbH & Co. KG880