EUCTR2016-003630-25-ES进行中（未招募）1 期
A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,640
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
- •2) Male or female subjects who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
- •a) Subjects who completed GS-US-417-0301, GS-US-417-0302, or GS-US-417-0303 on study drug OR
- •b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
- •3) Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE;
- •4) Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study
- •5)Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception, during the study and through 35 days (female) or 90 days (male) after their last dose of study drug or longer as indicated by the product label of the subject's concurrent csDMARD therapy.
- •6)Subjects receiving protocol permitted RA medications should be on a stable dose (defined as no change in prescription) within 7 days or 5 half lives (whichever is longer) prior to the first administration of study drug on Day 1.
- •7) Subjects, who meet study drug interruption criteria at Day 1, are eligible to enter into the LTE, but should not start study drug until deemed medically appropriate.
- •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 1320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1320
排除标准
- •1) Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- •2) Known hypersensitivity to the study drug or its excipients.
- •3) Any medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator.
- •4) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ.
- •5) Administration of a live/ attenuated vaccine within 30 days prior to Day 1
- •6) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria)
- •7) History of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
- •8) Any condition or circumstances which in the opinion of the investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements
- •9) Use of prohibited medication as outlined in the protocol
- •10) Subjects who meet discontinuation criteria as outlined in outlined in the protocol
研究者
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