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

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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).


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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Egg Harbor Township, New Jersey 08234
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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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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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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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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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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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Charlotte, North Carolina 28207
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Charlottesville, Virginia 22911
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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6035 Shallowford Road
Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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222 Piedmont Avenue
Cincinnati, Ohio 45229
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Columbia, Maryland 21045
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1665 43rd Street South
Fargo, North Dakota 58103
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Farmington, Connecticut 06032
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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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Great Neck, New York 11021
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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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La Jolla, California 92093
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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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Lone Tree, Colorado
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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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Miami Springs, Florida 33166
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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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1428 Madison Ave
New York, New York 10029
(212) 241-6500
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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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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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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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Richmond, Virginia 23249
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Rochester, Minnesota 55905
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#65 - 25 Carrera 54
Rosario, 111221
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660 S Euclid Ave
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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San Antonio, Texas 78229
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San Antonio, Texas 78265
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1305 Wonder World Drive
San Marcos, Texas 78666
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Santa Clarita, California 91350
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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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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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Tulsa, Oklahoma 74137
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Washington, District of Columbia 20007
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Zephyrhills, Florida 33542
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