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
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New York, New York 10065
1760
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New York, NY
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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...
493
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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...
344
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Chapel Hill, NC
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
676
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Jacksonville, FL
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610 3rd St # 206
Macon, Georgia 31201
493
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Macon, GA
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750 Highland Avenue
Madison, Wisconsin 53792
394
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260 Lookout Pl # 201
Maitland, Florida 32751
788
mi
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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...
333
mi
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Nashville, TN
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Orlando, Florida 32806
796
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Orlando, FL
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701 West Morse Boulevard
Winter Park, Florida 32789
791
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164
mi
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Ann Arbor, MI
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191 Biltmore Avenue
Asheville, North Carolina 28801
303
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
424
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Atlanta, GA
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981
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Aventura, FL
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Baton Rouge, Louisiana 70809
801
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Bellevue, Washington 98004
2000
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Bethlehem, Pennsylvania 18015
234
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643
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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...
524
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Charleston, SC
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Charlotte, North Carolina 28207
350
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1215 Lee Street
Charlottesville, Virginia 22908
277
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Chattanooga, Tennessee 37421
360
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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,...
274
mi
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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...
270
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Chicago, IL
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10123 Alliance Road
Cincinnati, Ohio 45014
87
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Cincinnati, OH
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98
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94
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Cincinnati, Ohio 45267
94
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3001 Executive Drive
Clearwater, Florida 33762
834
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Clinton, Utah 84015
1518
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Colorado Springs, Colorado 80907
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Detroit, Michigan 48202
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Germantown, Tennessee 38138
501
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Great Neck, New York 11021
492
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539
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Hamden, CT
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Houston, Texas 77098
994
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425 Volker Boulevard
Kansas City, Missouri 64131
619
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Kinston, North Carolina 28501
440
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Kinston, NC
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1926
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La Jolla, CA
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7000 West Colfax Avenue
Lakewood, Colorado 80215
1166
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2080 Century Park East
Los Angeles, California 90067
1980
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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...
188
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Mar Del Plata,
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Marietta, Georgia 30060
425
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146
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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...
330
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Minneapolis, Minnesota 55455
624
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Miramar, Florida 33025
978
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1954
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Modesto, California 95355
2032
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Naples, Florida 34102
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New Port Richey, Florida
814
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New York, New York 10016
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478
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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
275
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Ogden, Utah 84405
1514
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
850
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Orange, California 92868
1959
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Orlando, Florida 32803
795
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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...
416
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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...
490
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342
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Richmond, VA
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335
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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...
559
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2801 Capitol Avenue
Roseville, California 95661
2042
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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...
397
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Salisbury, North Carolina 28144
328
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30 North 1900 East
Salt Lake City, Utah 84132
1510
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San Diego, California 92103
1951
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San Diego, California 92115
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San Diego, California 92123
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Santa Monica, California 90404
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Shreveport, Louisiana 71103
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Troy, Michigan 48098
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Urbana, Illinois 61801
274
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700 Northeast 87th Avenue
Vancouver, Washington 98664
2022
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502 Centennial Boulevard
Voorhees, New Jersey 08043
427
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Whittier, California 90602
1962
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