EUCTR2018-003351-37-GB进行中（未招募）1 期
A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE
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
- 2,600
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
- •Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
- •Participants must have at least one of the following characteristics:
- •Documented evidence of a VTE prior to this study
- •At least 60 years of age or older
- •A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m2), or
- •Age 50 to less than 60 years AND BMI 25 to less than 30 kg/m2.
- •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 2080
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 520
排除标准
- •Participants must not have any problems taking a tumor necrosis factor (TNF) inhibitor.
- •Participants must not be pregnant or breastfeeding.
- •Participants must not have had more than one VTE.
- •Participants must not have cancer.
- •Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
- •Participants must not have had a live vaccine within four weeks of study start.
- •Participants must not have participated in any other clinical trial within four weeks of study randomisation
- •Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.
研究者
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