PER-041-15已完成未知
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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
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
研究者
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