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
88
sites
Houston, Texas 77098
1890
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Houston, TX
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
2072
mi
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Birmingham, AL
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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...
2329
mi
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Chapel Hill, NC
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
2459
mi
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Jacksonville, FL
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610 3rd St # 206
Macon, Georgia 31201
2252
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Macon, GA
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750 Highland Avenue
Madison, Wisconsin 53792
1615
mi
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Madison, WI
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260 Lookout Pl # 201
Maitland, Florida 32751
2543
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Maitland, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1971
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Nashville, TN
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Orlando, Florida 32806
2549
mi
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Orlando, FL
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701 West Morse Boulevard
Winter Park, Florida 32789
2545
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Winter Park, FL
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1902
mi
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Ann Arbor, MI
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191 Biltmore Avenue
Asheville, North Carolina 28801
2188
mi
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Asheville, NC
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
2173
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Atlanta, GA
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2724
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Aventura, FL
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Baton Rouge, Louisiana 70809
2035
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Baton Rouge, LA
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Bellevue, Washington 98004
6
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Bellevue, WA
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Bethlehem, Pennsylvania 18015
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Bethlehem, PA
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2485
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Boston, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
2422
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Charleston, SC
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Charlotte, North Carolina 28207
2283
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Charlotte, NC
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1215 Lee Street
Charlottesville, Virginia 22908
2284
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Charlottesville, VA
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Chattanooga, Tennessee 37421
2090
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Chattanooga, TN
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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,...
1732
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
1737
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Chicago, IL
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10123 Alliance Road
Cincinnati, Ohio 45014
1968
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Cincinnati, OH
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1966
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Cincinnati, OH
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1967
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Cincinnati, OH
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Cincinnati, Ohio 45267
1967
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3001 Executive Drive
Clearwater, Florida 33762
2520
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Clearwater, FL
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Clinton, Utah 84015
677
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Clinton, UT
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Colorado Springs, Colorado 80907
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Denver, CO
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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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Great Neck, NY
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2431
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Hamden, CT
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425 Volker Boulevard
Kansas City, Missouri 64131
1505
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Kansas City, MO
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Kinston, North Carolina 28501
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Kinston, NC
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1049
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La Jolla, CA
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7000 West Colfax Avenue
Lakewood, Colorado 80215
1017
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Lakewood, CO
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2080 Century Park East
Los Angeles, California 90067
959
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Los Angeles, CA
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
1938
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Louisville, KY
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Mar Del Plata,
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Marietta, Georgia 30060
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Marietta, GA
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2032
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Mentor, OH
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
1687
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Minneapolis, Minnesota 55455
1393
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Miramar, Florida 33025
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Miramar, FL
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999
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Mission Viejo, CA
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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
678
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
1518
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Orange, California 92868
984
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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...
2373
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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...
2374
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Poughkeepsie, NY
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2350
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Richmond, VA
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2343
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Richmond, VA
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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...
1450
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Rochester, MN
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2801 Capitol Avenue
Roseville, California 95661
627
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Roseville, CA
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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...
1718
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Saint Louis, MO
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Salisbury, North Carolina 28144
2281
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30 North 1900 East
Salt Lake City, Utah 84132
702
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San Diego, California 92103
1063
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San Diego, California 92115
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San Diego, California 92123
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San Francisco, California 94143
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Santa Monica, California 90404
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2
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Seattle, WA
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Shreveport, Louisiana 71103
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Suwanee, GA
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1456
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Topeka, KS
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Troy, Michigan 48098
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Tyler, TX
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Urbana, Illinois 61801
1761
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700 Northeast 87th Avenue
Vancouver, Washington 98664
139
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502 Centennial Boulevard
Voorhees, New Jersey 08043
2386
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Whittier, California 90602
969
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