CTRI/2017/08/009477已完成3 期
A Long-Term Extension Study to Evaluate the Safety of filgotinib in Subjects with Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 46
- 主要终点
- Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and
研究概览
简要总结
The primary objective of this study is to observe the long term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead sponsored filgotinib treatment study in Crohns disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial • Must have met all eligibility criteria from a Gilead-sponsored CD parent protocol • Females of childbearing potential must have a negative pregnancy test at Day 1 • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method of contraception as described in the study protocol, for the duration described • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug • Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for CD.
排除标准
- •â€¢ Known hypersensitivity to the study drug • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol • Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol • Use of prohibited medications as outlined in the study protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
结局指标
主要结局
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and
时间窗: Up to 432 weeks
Abnormal Clinical Laboratory Tests
时间窗: Up to 432 weeks
次要结局
- Change from Baseline in Crohns Disease Activity Index (CDAI) Scores(Baseline and up to 432 weeks)
- Change from Baseline in PRO2 Scores(PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.)
研究者
研究点 (46)
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