EUCTR2015-003335-35-GR进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •Adult male or female, at least 18 years old.
- •Diagnosis of RA for = 3 months.
- •Subjects have been treated with bDMARD therapy for RA in the past and failed at least 1 bDMARD in the past, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.
- •Subjects have been receiving csDMARD therapy = 3 months and on a stable dose for = 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
- •Meets the following criteria: = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- •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 338
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- •History of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
研究者
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