EUCTR2020-002673-10-HU进行中（未招募）1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants 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
- 80
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
- •Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
- •Have moderately to severely active RA defined by the presence of =6 swollen joints (based on 66 joint count) and =6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
- •Have at least 1 of the following:
- •- positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
- •- previous radiographs documenting bony erosions in hands or feet consistent with RA
- •Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
- •Demonstrated an inadequate response to, or loss of response or intolerance to:
- •- at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
- •- at least 1 biologic DMARD/tsDMARD treatment
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Class IV RA according to ACR revised response criteria
- •Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:
- •- basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
- •- cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
- •Have presence of confirmed cervical dysplasia
- •Have any of the following:
- •- Human immunodeficiency virus (HIV) infection
- •- Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction [PCR] positive for HBV DNA)
- •- Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
- •- Active tuberculosis (TB)
- •Have failed more than 2 biologic DMARDs or tsDMARDs (e.g. excluded if have failed 2 bDMARDs and 1 tsDMARD)
研究者
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