A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis - GS-US-417-0304 / FINCH 304

Gilead Sciences0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1) 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 or GS-US-417-0302 on study drug OR
•b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
•2) Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE;
•3) Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study
•4) 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.
•5) 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.
•6) 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.

•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 the protocol

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