EUCTR2015-003334-27-BG进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 975
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 = 6 weeks.
- •Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
- •Subjects with prior exposure to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) other than MTX may be enrolled if completed the washout period.
- •Subject meets the following disease activity criteria: = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- •= 1 bone erosion on x-ray (by local reading) OR in the absence of a documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening.
- •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 731
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 244
排除标准
- •Intolerant to MTX.
- •Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- •Prior exposure to any bDMARD(s).
- •History of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
研究者
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