EUCTR2015-001275-50-AT进行中（未招募）1 期
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive
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
- •a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification of RA within the past 6 months
- •b) Subjects must meet at least one of the following criteria:
- •i) CRP > 0.3mg/dL (ULN)
- •ii) ESR = 28mm/hr
- •c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at both screening and Day 1 (Appendix 11)
- •d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
- •e) Subjects have an SDAI > 11
- •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 1350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •a) Subjects at risk for tuberculosis
- •b) Subjects with recent acute infection
- •c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections.
- •d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic squamous or basal skin cell carcinoma, or cervical carcinoma in situ
- •e) Creatinine clearance < 40 mL/min (Cockroft-Gault formula)
研究者
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3 期
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate NaiveRheumatoid Arthritis10003816NL-OMON43711Bristol-Myers Squibb24