2024-513919-27-00招募中3 期
A Multicenter, Open-label, 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
- 3 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 16
- 主要终点
- Safety, evaluated through AEs, clinical laboratory tests, and vital signs.
研究概览
简要总结
To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA
研究设计
- 分配方式
- Randomized
- 主要目的
- Open label
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Able and willing to sign the informed consent as approved by the IRB/IEC. Written consent must be provided before initiating any Day -1 evaluations for this study. Subjects must have read and understood the ICF, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
- •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-4170301, 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.
- •Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE.
- •Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study.
- •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 after their last dose of study drug or longer as indicated by the product label of the subject's concurrent csDMARD therapy.
- •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 LTE study drug on Day 1, as much as possible.
- •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 as outlined in protocol section 3.5.1.
排除标准
- •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.
- •Known hypersensitivity to the study drug or its excipients.
- •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.
- •Administration of a live/ attenuated vaccine within 30 days prior to Day
- •Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria).
- •History of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia).
- •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.
- •Use of prohibited medication as outlined in the protocol.
- •Subjects who meet discontinuation criteria in outlined in the protocol.
结局指标
主要结局
Safety, evaluated through AEs, clinical laboratory tests, and vital signs.
Safety, evaluated through AEs, clinical laboratory tests, and vital signs.
次要结局
- ACR-N responses in each arm.
研究者
Clinical Trials Information desk
Scientific
Alfasigma S.p.A.
研究点 (16)
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