Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Status: | Enrolling by invitation |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | March 17, 2017 |
End Date: | October 2022 |
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
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 Crohn's disease (CD).
adults who have completed or met protocol specified efficacy discontinuation criteria in a
prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).
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 a Gilead-sponsored CD parent protocol, GS-US-419-4015,
GS-US-419-4016 or GS-US-419-3895
- 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(s) 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
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 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.
We found this trial at
92
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
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University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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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 Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
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Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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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](/wp-content/uploads/logos/university-of-wisconsin-hospital-and-clinics.jpg)
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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550 1st Avenue
New York, New York 10016
New York, New York 10016
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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601 East Rollins Street
Orlando, Florida 32803
Orlando, Florida 32803
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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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](/wp-content/uploads/logos/washington-university-school-of-medicine.png)
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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2093 Health Drive Southwest
Wyoming, Michigan 49519
Wyoming, Michigan 49519
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