Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Status: | Enrolling by invitation |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | February 23, 2017 |
End Date: | October 2022 |
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
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 ulcerative colitis (UC).
adults who have completed or met protocol specified efficacy discontinuation criteria in a
prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
Key Inclusion Criteria:
- 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 enrolled in Gilead-sponsored UC parent protocol GS-US-418-3898
- Must have completed all required procedures or met protocol specified efficacy
discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
- Females of childbearing potential must have a negative pregnancy test at Day 1
- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as
described in the 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
Key Exclusion Criteria:
- 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 or sponsor,
would make the subject 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 participants
- Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
80
sites
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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601 East Rollins Street
Orlando, Florida 32803
Orlando, Florida 32803
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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