A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/14/2019
Start Date:May 21, 2014
End Date:December 26, 2020

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Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

This phase III, double blind, placebo-controlled, multicenter study will investigate the
efficacy and safety of etrolizumab during induction and maintenance of remission in
participants with moderately to severely active ulcerative colitis (UC) who have been
previously exposed to TNF inhibitors.


Inclusion Criteria:

- Moderately to severely active UC as determined by the Mayo Clinic Score assessment
(MCS)

- Washout of anti-TNF therapy for at least 8 weeks preceding Day 1

- Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral
corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP),
or methotrexate (MTX) if doses have been stable during the screening period

- Use of highly effective contraception as defined by the protocol

- Must have received a colonoscopy within the past year or be willing to undergo a
colonoscopy in lieu of a flexible sigmoidoscopy at screening

- Treatment within 5 years prior to screening with one or two induction regimines that
contain TNF inhibitors (including TNF inhibitor biosimilars)

Exclusion Criteria:

- A history of or current conditions and diseases affecting the digestive tract, such as
indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic
mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous
colonic polyps

- Prior or planned surgery for UC

- Past or present ileostomy or colostomy

- Any prior treatment with etrolizumab or other anti-integrin agents (including
natalizumab, vedolizumab, and efalizumab) and rituximab

- Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)

- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis

- Evidence of or treatment for Clostridium difficile clinically significant
cytomegalovirus (CMV) colitis within 60 days prior to Day 1
We found this trial at
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Baton Rouge, Louisiana 70809
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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610 3rd St # 206
Macon, Georgia 31201
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750 Highland Avenue
Madison, Wisconsin 53792
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260 Lookout Pl # 201
Maitland, Florida 32751
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Orlando, Florida 32806
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701 West Morse Boulevard
Winter Park, Florida 32789
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191 Biltmore Avenue
Asheville, North Carolina 28801
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Bellevue, Washington 98004
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Bethlehem, Pennsylvania 18015
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28207
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1215 Lee Street
Charlottesville, Virginia 22908
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Chattanooga, Tennessee 37421
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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10123 Alliance Road
Cincinnati, Ohio 45014
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Cincinnati, Ohio 45267
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3001 Executive Drive
Clearwater, Florida 33762
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Clinton, Utah 84015
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Colorado Springs, Colorado 80907
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Detroit, Michigan 48202
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Germantown, Tennessee 38138
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Great Neck, New York 11021
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Houston, Texas 77098
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425 Volker Boulevard
Kansas City, Missouri 64131
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Kinston, North Carolina 28501
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7000 West Colfax Avenue
Lakewood, Colorado 80215
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2080 Century Park East
Los Angeles, California 90067
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Marietta, Georgia 30060
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Minneapolis, Minnesota 55455
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Miramar, Florida 33025
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Modesto, California 95355
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Naples, Florida 34102
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New Port Richey, Florida
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New York, New York 10016
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New York, New York 10065
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Norfolk, Virginia 23502
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Norman, Oklahoma 73069
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North Miami Beach, Florida 33162
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Oak Lawn, Illinois 60453
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Ogden, Utah 84405
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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Orange, California 92868
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Orlando, Florida 32803
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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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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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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2801 Capitol Avenue
Roseville, California 95661
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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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Salisbury, North Carolina 28144
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30 North 1900 East
Salt Lake City, Utah 84132
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San Diego, California 92103
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Santa Monica, California 90404
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Shreveport, Louisiana 71103
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Urbana, Illinois 61801
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700 Northeast 87th Avenue
Vancouver, Washington 98664
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502 Centennial Boulevard
Voorhees, New Jersey 08043
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Whittier, California 90602
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