Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis



Status:Enrolling by invitation
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:February 28, 2017
End Date:May 2022

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A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

The primary objective of this study is to evaluate the long-term safety and tolerability of
filgotinib in participants who have completed one of the parent studies of filgotinib in
rheumatoid arthritis (RA).


Key Inclusion Criteria:

- Males or females who may benefit from filgotinib as judged by the investigator AND who
completed a Gilead sponsored filgotinib parent study for RA as outlined below:

- Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug

- OR

- Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder
status

- Females of childbearing potential must have a negative pregnancy test prior to first
dose of study drug in the long term extension (LTE)

- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to protocol-approved methods of contraception

Key Exclusion Criteria:

- Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would
put the participant at risk by participating in the study or would interfere with
study assessments/data interpretation, per judgment of the investigator

- Known hypersensitivity to the study drug or its excipients

- Any medical condition which would put the participant at risk by participating in the
study or would interfere with study assessments/data interpretation, per judgment of
the investigator

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
74
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Worcester, Massachusetts 01610
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico
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Aventura, Florida 33180
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3406 College Street
Beaumont, Texas 77701
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Bethlehem, Pennsylvania 18015
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Brooklyn, NY
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Brooklyn, New York 11201
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Caba,
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Carrollton, TX
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Charlotte, North Carolina 28204
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Columbia, South Carolina 29204
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Corpus Christi, Texas 78404
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Covina, California 91723
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Cumberland, Maryland 21502
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Decatur, Georgia 30033
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Detroit, Michigan 48202
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
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Elizabethtown, Kentucky 42701
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Frederick, Maryland 21702
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Freehold, New Jersey 07728
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Gilbert, AZ
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Greenville, North Carolina 27834
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Hagerstown, Maryland 21740
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7100 U.S. 98
Hattiesburg, Mississippi 39402
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Hemet, California 62543
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Jacksonville, Florida 32209
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky 40504
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Lincoln, Nebraska 68512
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Memphis, Tennessee 38119
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Mesquite, Texas 75150
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Miami, Florida 33015
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Miami Lakes, Florida 33014
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Middleburg Heights, Ohio 44130
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8220 Nigels Drive
Myrtle Beach, South Carolina 29572
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New Port Richey, Florida 34652
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Oklahoma City, Oklahoma 73103
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Orangeburg, South Carolina 29118
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Orlando, Florida 32804
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Palm Desert, California 92260
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19152
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Phoenix, Arizona 85018
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140 Southwest 84th Avenue
Plantation, Florida 33324
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949 Calhoun Place
Riverside, California 92518
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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Saint Louis, Missouri 63141
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Saint Louis, Missouri 63117
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Salisbury, North Carolina 28144
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Springfield, Illinois 62703
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Toms River, New Jersey 08755
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Victorville, California 92395
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Whittier, California 90606
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Worcester, Massachusetts 01605
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1200 Broadcasting Road
Wyomissing, Pennsylvania 19610
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Wyomissing, Pennsylvania 19610
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