A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,731
- 试验地点
- 684
- 主要终点
- Proportion of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
- •Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
- •Have 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 long term extension (LTE)
- •Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception
排除标准
- •Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant 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 which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
干预措施: Filgotinib (Drug)
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
干预措施: Placebo to match filgotinib (Drug)
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
干预措施: Filgotinib (Drug)
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
干预措施: Placebo to match filgotinib (Drug)
Open Label Phase: Filgotinib 200 mg
Filgotinib 200 mg for up to 6 years
干预措施: Filgotinib (Drug)
Open Label Phase: Filgotinib 100 mg
Filgotinib 100 mg for up to 6 years
干预措施: Filgotinib (Drug)
结局指标
主要结局
Proportion of Participants Experiencing Adverse Events (AEs)
时间窗: Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
时间窗: Up to 6 years
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 to Week 376 (end of study)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters
时间窗: Day 1 to Week 376 (end of study)
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters
时间窗: Day 1 to Week 376 (end of study)
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
时间窗: Baseline and At Week 312
SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Change From Baseline in Pulse Rate
时间窗: Baseline and At Week 312
Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Change From Baseline in Respiration Rate
时间窗: Baseline and At Week 312
Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
次要结局
- Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm(Up to 6 years)
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70(At Week 312)