台灣臨床試驗主持人資料庫|TPIDB

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberGS-US-417-0304

NCT Number(ClinicalTrials.gov Identfier)NCT03025308

2018-05-25 - 2028-12-31

Phase III

Recruiting1

Terminated9

ICD-10M06

Other rheumatoid arthritis

ICD-10M06.9

Rheumatoid arthritis, unspecified

ICD-9714.0

Rheumatoid arthritis

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor

Gilead Sciences
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 吳詹永嬌無

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

陳勇志無
曾文逸無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 田雅之無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

邱瑩明未分科
洪明暉無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳宏安無

Chi Mei Medical Center

Co-Principal Investigator

林永章無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 曾瑞成無

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗無

Chung Shan Medical University Hospital

Co-Principal Investigator

王世叡無
梁培英無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳相成無

Tri-Service General Hospital

Co-Principal Investigator

劉峰誠無
盧俊吉無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yao-Fan Fang 無

Linkou Chang Gung Medical Foundation

Taiwan National PI

方耀凡

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Stop recruiting

Audit

None

Principal Investigator KO-JEN LI 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Chi-Ching Chang 無

Taipei Medical University Hospital

Co-Principal Investigator

Tzn-Min Lin 無

The Actual Total Number of Participants Enrolled

1 Stop recruiting

Audit

None

Principal Investigator Joung-Liang Lan 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Rheumatoid Arthritis

Objectives

The primary objective of this study is:  To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA. The secondary objectives of this study are:  To evaluate the long-term efficacy of filgotinib in subjects with RA  To evaluate the long-term effects of filgotinib on subject-reported outcomes, such as disability, fatigue, and quality of life.

Test Drug

Filgotinib

Active Ingredient

Filgotinib

Dosage Form

tablet
tablet

Dosage

100 mg and 200 mg per tablet

Endpoints

The primary endpoint is:
 Safety, evaluated through AEs, clinical laboratory tests, and vitalsigns.
Secondary endpoint:
 ACR-N over time in each arm
Exploratory Endpoints:
 Achievement of ACR20/50/70
 EULAR responses; ACR/EULAR remission
 Evolution of CDAI, SDAI, and DAS28(CRP) over time
 Evolution of patient reported outcomes over time

Inclution Criteria

Key Inclusion Criteria
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, 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
2) Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE;
3) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods
of contraception.

Exclusion Criteria

Key Exclusion Criteria
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.

The Estimated Number of Participants

Taiwan

141 participants
Global

participants