A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease
Published: 07/12/2017
General Information:
Study Objective
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).
Phase of study
open label extension
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
crohns-disease
Severity
Moderate
Severe
Eligibility Criteria
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 met all eligibility criteria from a Gilead-sponsored CD parent protocol
- 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
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, 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.
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Study Details:
Description of Treatment or Intervention (Mechanism of Action)
- This is a long-term extension study. Patients who have completed or did not respond well to study treatment in the prior Gilead study may participate in the study. The dose received in this study will vary and depends on what happened in the prior Gilead study.
- Mechanism of Action: Filgotinib is an oral investigational drug called a “JAK1 inhibitor” that is taken as a pill once a day. JAK1 inhibitors may slow damage to the digestive system by slowing down the activity of immune cells.
Possible Risks & Side Effects
- The study involves taking an investigational (experimental) drug. Since the drug is investigational, there may be risks that are not yet identified. The investigational drug affects the immune system, and may weaken the body’s ability to fight off infection. A possible risk of being in the study is an increased risk of infection. Infections have been reported in previous studies of this drug.
- Some side effects have been seen in people who have taken this study drug before. Across different studies of this study drug in different types of patients, some of the more common side effects include headache, sleepiness and fatigue, nausea, upper abdominal discomfort, and abnormal taste in mouth.
- At this time, the effect of the study drug on pregnancy is not known. Strict use of birth control must be followed for both men and women.
- With any drug there is a risk of allergic reaction, which can range from mild (such as itching) to serious (such as problems breathing).
- The study requires blood draws, stool samples, and ECGs. Collecting a blood sample from a vein may cause pain, bruising, lightheadedness, fainting, and very rarely, infection or injury to the nerves at the site of the needle stick. After you have an ECG, you may have mild irritation, slight redness, and itching on your skin where the recording patches are attached.
- You may be asked personal questions during the study to understand the effect the disease has on your life.
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Contact Information:
Site Locations
Advanced Medical Research Center
1690 Dunlawton AVE
Suite 110
Port Orange,
Florida 32127
Advanced Pharma - Miami
2950 Northwest 83rd St
Miami,
Florida 33147
AGA Clinical Research Associates, LLC
3205 Fire Road, Suite 4
Egg Harbor Township,
New Jersey 08234
Atlantic Gastroenterology Associates
4395 Johns Creek Pkwy
Suite 2020
Atlanta,
Georgia 30024
Carolinas GI Research
2601 Lake Dr
Suite 201
Raleigh,
North Carolina 27606
Cedars-Sinai Medical Center, Inflammatory Bowel Disease Center
8730 Alden Dr Thalians Bldg
W203
Los Angeles,
California 90048
Center for Digestive Health
4550 Investment Drive
Suite 260
Troy,
Michigan 48098
Charlotte Gastroenterology and Hepatology
2015 Randolph Road
Suite 208
Charlotte,
North Carolina 28210
Charlottesville Medical Research
325 Winding River Lane
Charlottesville,
Virginia 22911
Chevy Chase Clinical Research
5550 Friendship Blvd T-90
Chevy Chase,
Maryland 20815
Clearview Medical Research, LLC
27141 Hidaway AVE
Suite 103
Santa Clarita,
California 91351
Clinical Associates in Research Therapeutics of America
1200 Brooklyn AVE
Suite 150
San Antonio,
Texas 78212
Clinical Research Institute of Michigan, LLC
30795 23 Mile Road
Suite 206
Chesterfield,
Michigan 48047
ClinSearch
6035 Shallowford Road
Suite 109
Chattanooga,
Tennessee 37421
Connecticut GI, PC
21 South Road
Suite 100
Farmington,
Connecticut 06032
Consultants for Clinical Research
2925 Vernon Place
#200
Cincinnati,
Ohio 45219
Cordova Research Institute
7815 Coral Way
Suite 103
Miami,
Florida 33155
Delta Research Partners
608 Grammot ST
Monroe,
Louisiana 71201
DHAT Research Institute
7150 N President George Bush HWY
Suite 201
Garland,
Texas 75044
Digestive Health Specialists of the Southeast
480 Honeysuckle Road
Dothan,
Alabama 36305
Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
6400 Fannin Street Unit 1400
Houston,
Texas 77030
Fargo Gastroenterology and Hepatology Clinic
1665 43rd Street South, Suite 100
Fargo,
North Dakota 58103
Florida Center for Gastroenterology
8250 Bryan Dairy Road, Suite 200
Largo,
Florida 33777
Florida Hospital
601 East Rollins Street
Orlando,
Florida 32803
Florida Medical Clinic, PA, Clinical Research Division
38135 Market Square Clinical Research Division
Zephyrhills,
Florida 33542
Florida Digestive Health Specialists
10910 Technology Terrace
Lakewood Ranch,
Florida 34211
Gastroenterology Associates of Western Michigan, P.L.C.
2093 Health Drive SW, Suite 201
Wyoming,
Michigan 49519
Gastro Center of Maryland
7120 Minstrel Way, Suite 100
Columbia,
Maryland 21045
Gastroenterology Center of the MidSouth, P.C.
1310 Wolf Park Drive
Germantown,
Tennessee 38138
Gastroenterology Associates of Central Georgia, LLC
610 Third Street, Suite 204
Macon,
Georgia 31201
Gastroenterology Associates of Orangeburg
1131 Cook Road
Orangeburg,
South Carolina 29118
Gastroenterology Associates of Tidewater
112 Gainsborough Square, Suite 200
Chesapeake,
Virginia 23320
Gastroenterology Group of Naples
1064 Goodlette Road
Naples,
Florida 34102
Gastroenterology Research of America
8550 Datapoint Dr., Suite 230
San Antonio,
Texas 78229
Georgetown University
3800 Reservoir Road NW Main Building Second Floor
Washington,
District of Columbia 20007
GI Associates of New Hampshire
2801 W. Kinnickinnic River Parkway
Milwaukee,
Wisconsin 53215
GI Specialists of Georgia
711 Canton Road Northeast, Suite 300
Marietta,
Georgia 30060
Gordon and Leslie Diamond Health Care Centre
5153-2775 Laurel Street
Vancouver,
British Columbia V5Z1M9
Great Lakes Medical Research - Mentor
8877 Mentor Avenue
Mentor,
Ohio 44060
Gulf Region Clinical Research Institute
8333 North Davis Highway 4th Floor
Pensacola,
Florida 32514
Heritage Medical Research Clinic
3280 Hospital Drive NW, TRW Building, 6th Floor
Calgary,
Alberta T2N4Z6
Indiana University Health University Hospital
550 North University Boulevard, Suite 1605 C
Indianapolis,
Indiana 46202
Inquest Clinical Research
1682 W. Baker Road, Suite B
Baytown,
Texas 77521
Investigative Clinical Research - Annapolis
621 Ridgely Ave. Ste. 401
Annapolis,
Maryland 21401
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1118
New York,
New York 10029
Kansas City Research Institute
6675 Holmes Road, Suite 430
Kansas City,
Missouri 64131
Las Vegas Medical Research
8530 W Sunset Rd, Suite 300
Las Vegas,
Nevada 89113
London Health Sciences University Hospital, University Of Western Ontario
339 Windermere Road, Room ALL-100
London,
Ontario N6A5A5
Louisiana Research Center
1800 East 70th Street
Shreveport,
Louisiana 71105
Massachusetts General Hospital - Crohn's and Colitis Center
165 Cambridge St Floor 9
Boston,
Massachusetts 02114
Mayo Clinic
200 First Street SW
Rochester,
Minnesota 55905
McMaster University
1280 Main Street West
Hamilton,
Ontario L8S4K1
Mcguire Dvamc
1201 Broad Rock Blvd GI Dept 111N
Richmond,
Virginia 23298
Meritus Center for Clinical Research
11110 Medical Campus Rd, Suite 246
Hagerstown,
Maryland 21742
New York Langone Long Island Clinical Research Associates
1000 Northern Boulevard, Suite 160
Great Neck,
New York 11021
Northwell Health
600 Northern Boulevard, Suite 111
Great Neck,
New York 11021
Northwell Health
178 East 85th Street, Suite 4
New York,
New York 10028
NY Scientific
1517 Voorhies Avenue, Suite 5
Brooklyn,
New York 11235
NYU Langone Medical Center
240 East 38th Street
New York,
New York 10016
Options Health Research
Options Health Research 1145 South Utica, Suite 807
Tulsa,
Oklahoma 74104
Paramount Medical Research & Consulting
18660 Bagley Rd, Suite 102B
Middleburg Heights,
Ohio 44130
PerCuro Clinical Research
200-1105 Pandora Avenue, Suite 430
Victoria,
British Columbia V8V3M9
Premier Medical Group of the Hudson Valley
243 North Road, Suite 304
Poughkeepsie,
New York 12601
Quality Medical Research
330 Wallace Road Suite 103 Quality Medical Research
Nashville,
Tennessee 37211
South Denver Gastroenterology
10103 Ridge Gate Parkway
Lone Tree,
Colorado 80124
Spring Gastroenterology
25410 Interstate 45 North
Humble,
Texas 77338
Texas Clinical Research Institute
1009 Magnolia Street
Arlington,
Texas 76012
Texas Digestive Disease Consultants
505 South Nolen Drive
Southlake,
Texas 76092
Texas Digestive Disease Consultants - San Marcos
1305 Wonder World Drive, Suite 200
San Marcos,
Texas 78130
Toronto Digestive Diseases Associates
4600 Highway 7, Unit 225
Vaughan,
Ontario L4L4Y7
University of California San Diego
9452 Medical Center Dr.
San Diego,
California 92093
University of Cincinnati Physicians - UC Physicians Office - Clifton, Divison of Digestive Diseases
222 Piedmont Avenue
Cincinnati,
Ohio 45267
University of Colorado Hospital
Mail Stop B158 Academic Office 1 12631 E. 17th Ave
Aurora,
Colorado 80045
University of Florida, Dept. of Medicine, Div. of Gastroenterology
1600 Southwest Archer Road HD 602
Gainesville,
Florida 32610
University of Iowa Hospitals and Clinics
200 Hawkins Drive JCP4574/Internal Medicine
Iowa City,
Iowa 52242
University of Louisville Clinical Trials Unit
505 S. Hancock St., CTR Building, Room 506 Dept of Medicine
Louisville,
Kentucky 40202
University of Maryland Medical Center
22 South Greene St Room N3W62
Baltimore,
Maryland 21201
University of Miami
1120 NW 14th Street Room 310
Miami,
Florida 33136
University of Saskatchewan
Royal University Hospital, 103 Hospital Drive
Saskatoon,
Saskatchewan S7N0W8
University of South Florida, South Tampa Center for Advanced Healthcare (CAHC)
South Tampa Center for Advanced Healthcare (CAHC) 2 Tampa General CircleFloor 1
Tampa,
Florida 33606
University of Virginia Health System
1215 Lee Street Box 800708
Charlottesville,
Virginia 22908
University of Wisconsin
1685 Highland Ave.
Madison,
Wisconsin 53705
Val R. Hansen, MD
520 Medical Drive, Suite 300
Bountiful,
Utah 84010
Virginia Commonwealth University
West Hospital, 1200 East Broad Street, 14th Floor PO Box 980341
Richmond,
Virginia 23298
Washington University School of Medicine
660 South Euclid Avenue Box 8124
St. Louis,
Missouri 63110
Pinnacle Clinical Research
5109 Medical Drive, Suite 200
San Antonio,
Texas 78229
Advanced Research
6280 W. Sample Rd, Suite 202
Coral Springs,
Florida 33067
Baylor College of Medicine
7200 Cambridge St., Suite 8B
Houston,
Texas 77030
Gastroenterology Consultants
1155 Mill Street
Reno,
Nevada 89502
Gastroenterology Research of America (GAME) - Gulfcoast Research Group
4100 South Shepherd Drive
Houston,
Texas 77098
Houston Methodist Hospital
6550 Fannin Street, Suite 101
Houston ,
Texas 77030
Kaiser San Francisco Division of Research
4141 Geary Blvd. #219
San Francisco,
California 94118
Kelsey Research Foundation
2727 W. Holcombe Boulevard Room #1152
Houston,
Texas 77025
Northwestern University
675 North Saint Clair Street
Chicago,
Illinois 60611
Peak Gastroenterology Associates
2920 N Cascade Ave
Colorado Springs,
Colorado 80907
Pinnacle Clinical Research, PLLC
3001 Bee Caves Road
Rollingwood,
Texas 78746
San Antonio Military Medical Center
3551 Rogers Brooke Drive
Fort Sam Houston,
Texas 78219
Susquehanna Research Group
4387 Sturbridge Drive
Harrisburg,
Pennsylvania 17110
University of Chicago
5758 South Maryland Avenue MC 9028, DCAM 0301
Chicago ,
Illinois 60637
University of Kansas Medical Center, Research Institute Inc.
3901 Rainbow Blvd
Kansas City,
Kansas 66160
University of Mississippi Medical Center
2500 North State Street 2 East
Jackson,
Mississippi 39216
Vanderbilt University
1211 21st Avenue South MAB 220
Nashville ,
Tennessee 37212
Mount Sinai Hospital
60 Murray Street 2nd floor, Rm 300
Toronto,
Ontario M5T 3L9
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