EUCTR2020-005303-39-GR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 425
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. Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA.
- •2. Participant has = 6 swollen joints (based on 66 joint count) and = 6 tender joints (based on 68 joint count) at baseline.
- •3. Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
- •4. Participants must be on stable dose of methotrexate (MTX).
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
研究者
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