EUCTR2014-000352-29-FR进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 560
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
- •- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
- •- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
- •- Hs-CRP equal or greater than 8 mg/L.
- •- Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
- •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 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •- Evidence of untreated or inadequately treated latent or active TB.
- •- Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
- •- History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
- •- May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
- •- Any second DMARD (Disease modifying anti-rheumatic drug) must be washed out prior to the first study dose.
研究者
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