EUCTR2015-003333-95-BG进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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 must have been on oral or parenteral MTX therapy = 3 months prior to the first dose of study drug.
- •Subjects meeting both: = 6 swollen joints and = 6 tender joints at screening and baseline, and hsCRP = 5 mg/L at screening
- •At least one of the following at Screening: = 3 bone erosions on x-ray OR = 1 bone erosion and a positive rheumatoid factor OR = 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
- •Subjects with prior exposure to at most one bDMARD (except ADA) may be enrolled (up to 20% of total study population)
- •Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
- •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 1125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 375
排除标准
- •Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- •Subjects who are considered inadequate responders to bDMARD therapy
- •History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
研究者
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