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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906
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Carrollton, TX
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2147 Northeast Coachman Road
Clearwater, Florida 33765
828
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Clearwater, FL
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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...
1970
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Los Angeles, CA
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
781
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Wichita, KS
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Albuquerque, New Mexico
1333
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Albuquerque, NM
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Aventura, Florida 33180
982
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Aventura, FL
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3406 College Street
Beaumont, Texas 77701
926
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Beaumont, TX
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Bethlehem, Pennsylvania 18015
407
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Bethlehem, PA
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280
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Brooklyn, NY
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Brooklyn, New York 11201
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Brooklyn, NY
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Caba,
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Charlotte, North Carolina 28204
349
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Charlotte, NC
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Columbia, South Carolina 29204
425
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Columbia, SC
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Corpus Christi, Texas 78404
1176
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Corpus Christi, TX
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Covina, California 91723
1952
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Covina, CA
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Cumberland, Maryland 21502
226
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Cumberland, MD
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911
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Dallas, TX
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772
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Debary, FL
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Decatur, Georgia 30033
433
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Decatur, GA
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Detroit, Michigan 48202
165
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Detroit, MI
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Duncansville, Pennsylvania 16635
244
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Duncansville, PA
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Eagan, Minnesota 55121
616
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Eagan, MN
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Elizabethtown, Kentucky 42701
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Frederick, Maryland 21702
300
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Frederick, MD
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Freehold, New Jersey 07728
461
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Freehold, NJ
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1650
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Gilbert, AZ
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Greenville, North Carolina 27834
429
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Greenville, NC
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Hagerstown, Maryland 21740
282
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Hagerstown, MD
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7100 U.S. 98
Hattiesburg, Mississippi 39402
698
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Hattiesburg, MS
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Hemet, California 62543
1913
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Hemet, CA
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411
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Huntsville, AL
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Jacksonville, Florida 32209
675
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Jacksonville, FL
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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...
627
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Kansas City, KS
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La Jolla, California 92093
1953
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La Jolla, CA
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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...
609
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Lebanon, NH
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Lexington, Kentucky 40504
156
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Lexington, KY
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Lincoln, Nebraska 68512
721
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Lincoln, NE
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Memphis, Tennessee 38119
508
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Memphis, TN
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Mesquite, Texas 75150
901
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Mesquite, TX
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Miami, Florida 33015
981
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Miami, FL
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Miami Lakes, Florida 33014
983
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Miami Lakes, FL
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Middleburg Heights, Ohio 44130
116
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Middleburg Heights, OH
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8220 Nigels Drive
Myrtle Beach, South Carolina 29572
487
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Myrtle Beach, SC
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New Port Richey, Florida 34652
810
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New Port Richey, FL
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Oklahoma City, Oklahoma 73103
849
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Oklahoma City, OK
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Orangeburg, South Carolina 29118
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Orlando, Florida 32804
792
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Orlando, FL
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Palm Desert, California 92260
1882
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Palm Desert, CA
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Palo Alto, California 94304
2100
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Philadelphia, Pennsylvania 19152
416
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Phoenix, Arizona 85018
1656
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1671
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896
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Plano, TX
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140 Southwest 84th Avenue
Plantation, Florida 33324
969
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Plantation, FL
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949 Calhoun Place
Riverside, California 92518
1912
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
175
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Saint Clair Shores, MI
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Saint Louis, Missouri 63141
408
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Saint Louis, MO
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Saint Louis, Missouri 63117
401
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Salisbury, North Carolina 28144
328
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Salisbury, NC
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1128
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San Antonio, TX
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Springfield, Illinois 62703
351
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Springfield, IL
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505
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Summerville, SC
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Toms River, New Jersey 08755
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Toms River, NJ
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Tucson, AZ
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750
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Tulsa, OK
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503
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Tupelo, MS
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1939
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Upland, CA
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Victorville, California 92395
1911
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Victorville, CA
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324
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Wheaton, MD
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Whittier, California 90606
1965
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Whittier, CA
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Worcester, Massachusetts 01610
604
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Worcester, MA
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Worcester, Massachusetts 01605
604
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1200 Broadcasting Road
Wyomissing, Pennsylvania 19610
372
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Wyomissing, Pennsylvania 19610
373
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