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

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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).


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
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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7000 Fannin St
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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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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610 3rd St # 206
Macon, Georgia 31201
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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701 West Morse Boulevard
Winter Park, Florida 32789
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Annapolis, Maryland 21401
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Arlington, Texas 76012
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Baytown, Texas 77512
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Bountiful, Utah 84010
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2001 Oriental Boulevard
Brooklyn, New York 11235
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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Charlottesville, Virginia 22911
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6035 Shallowford Road
Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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222 Piedmont Avenue
Cincinnati, Ohio 45229
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Columbia, Maryland 21045
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Egg Harbor Township, New Jersey 08234
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1665 43rd Street South
Fargo, North Dakota 58103
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Farmington, Connecticut 06032
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Fort Sam Houston, Texas 78234
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Gainesville, Florida 32610
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Garland, Texas 75044
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Germantown, Tennessee 38138
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Hagerstown, Maryland 21740
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Houston, Texas 77025
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Houston, Texas 77004
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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425 Volker Boulevard
Kansas City, Missouri 64131
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Lakewood Ranch, Florida 34211
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Lansdowne, Virginia 20176
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Las Vegas, Nevada 89113
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Long Beach, California 90822
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323 East Chestnut Street
Louisville, Kentucky 40202
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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Marietta, Georgia 30060
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Miami, Florida 33175
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Miami, Florida 33155
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Middleburg Heights, Ohio 44130
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Monroe, Louisiana 71201
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Naples, Florida 34102
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Nashville, Tennessee 37211
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New York, New York 10021
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Norfolk, Virginia 23502
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Orangeburg, South Carolina 29118
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601 East Rollins Street
Orlando, Florida 32803
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Rapid City, South Dakota 57701
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Richmond, Virginia 23249
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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San Antonio, Texas 78229
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1305 Wonder World Drive
San Marcos, Texas 78666
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Santa Clarita, California 91350
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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26103 Interstate 45
The Woodlands, Texas 77380
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Troy, Michigan 48098
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Washington, District of Columbia 20007
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Wauwatosa, Wisconsin 53226
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Zephyrhills, Florida 33542
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