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
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Moderate to Severe Rheumatoid Arthritis
- 发起方
- AbbVie Deutschland GmbH & Co. KG
- 入组人数
- 425
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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