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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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
420
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Chesapeake, VA
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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...
1208
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Houston, TX
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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...
362
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Indianapolis, IN
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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...
2136
mi
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Los Angeles, CA
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610 3rd St # 206
Macon, Georgia 31201
671
mi
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Macon, GA
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
899
mi
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Port Orange, FL
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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,...
989
mi
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Tampa, FL
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701 West Morse Boulevard
Winter Park, Florida 32789
936
mi
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Winter Park, FL
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Annapolis, Maryland 21401
281
mi
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Annapolis, MD
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Arlington, Texas 76012
1138
mi
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Arlington, TX
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624
mi
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Atlanta, GA
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1304
mi
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Aurora, CO
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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...
261
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Baltimore, MD
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Baytown, Texas 77512
1195
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Baytown, TX
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454
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Boston, MA
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Bountiful, Utah 84010
1644
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2001 Oriental Boulevard
Brooklyn, New York 11235
329
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Charlotte, North Carolina 28207
479
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Charlotte, NC
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Charlottesville, Virginia 22911
289
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Charlottesville, VA
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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...
291
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Charlottesville, VA
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6035 Shallowford Road
Chattanooga, Tennessee 37421
562
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Chattanooga, TN
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Chesterfield, Michigan 48098
166
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Chesterfield, MI
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262
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Chevy Chase, MD
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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,...
393
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Chicago, IL
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315
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Cincinnati, OH
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222 Piedmont Avenue
Cincinnati, Ohio 45229
314
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Columbia, Maryland 21045
256
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811
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Dothan, AL
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Egg Harbor Township, New Jersey 08234
339
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1665 43rd Street South
Fargo, North Dakota 58103
893
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Farmington, Connecticut 06032
366
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Gainesville, Florida 32610
871
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Garland, Texas 75044
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Germantown, Tennessee 38138
718
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334
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Great Neck, New York 11021
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Hagerstown, Maryland 21740
206
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Houston, Texas 77025
1209
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Houston, Texas 77004
1211
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Houston, TX
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1208
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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...
596
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425 Volker Boulevard
Kansas City, Missouri 64131
795
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La Jolla, California 92093
2124
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Lakewood Ranch, Florida 34211
1021
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Lansdowne, Virginia 20176
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993
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Largo, FL
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Las Vegas, Nevada 89113
1915
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1646
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Lone Tree, Colorado
1310
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Long Beach, California 90822
2138
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323 East Chestnut Street
Louisville, Kentucky 40202
405
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
486
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Marietta, Georgia 30060
617
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77
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Mentor, OH
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Miami, Florida 33175
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Miami, Florida 33155
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Miami Springs, Florida 33166
1125
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Middleburg Heights, Ohio 44130
108
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411
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Milwaukee, WI
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Monroe, Louisiana 71201
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Naples, Florida 34102
1107
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Nashville, Tennessee 37211
552
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551
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323
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New York, New York 10021
323
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
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Norfolk, Virginia 23502
413
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Orangeburg, South Carolina 29118
597
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601 East Rollins Street
Orlando, Florida 32803
938
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902
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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...
311
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3100 Duraleigh Road
Raleigh, North Carolina 27607
439
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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
644
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#65 - 25 Carrera 54
Rosario, 111221
2612
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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...
593
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San Antonio, Texas 78229
1354
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San Antonio, Texas 78265
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1305 Wonder World Drive
San Marcos, Texas 78666
1309
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Santa Clarita, California 91350
2140
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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...
1823
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Shreveport, Louisiana 71103
1006
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Southlake, Texas 76092
1131
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26103 Interstate 45
The Woodlands, Texas 77380
1192
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Troy, Michigan 48098
166
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Tulsa, Oklahoma 74137
952
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Washington, District of Columbia 20007
269
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298
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Zephyrhills, Florida 33542
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