EUCTR2017-004543-20-ES进行中（未招募）1 期
EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA
Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 98 人开始时间: 2018年10月25日最近更新:
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
- 入组人数
- 98
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
入选标准
- •Patients with PR according to Guerne and Weissman modified criteria (18) and with:
- •-Disease evolution > 3 months and < 24 months.
- •-ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
- •-Greater than 18 years of age.
- •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 98
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Persistent arthritis: (involvement in one or more joints > 1 week).
- •-Criteria of other rheumatic diseases (RA, SLE, etc.).
- •-Evidence of radiographic damage (join erosions).
- •-Absence of ACPA or RF.
- •-Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
- •-Steroid treatment one month before study entry.
- •-Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.
- •-Pregnant women or who want to be pregnant during the study.
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