A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/17/2019
Start Date:August 12, 2014
End Date:August 20, 2020

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Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter
study will investigate the efficacy and safety of etrolizumab in maintenance of remission in
participants with moderately to severely active UC who are naive to TNF inhibitors and
refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.


Inclusion Criteria:

- Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic
subscore greater than or equal to (>=) 2 as determined by the central reading
procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding
subscore >=1, and a stool frequency subscore >= 1 during the screening period (prior
to Day 1)

- Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as
determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed
during screening, 4-16 days prior to Day 1

- Naive to treatment with any anti-TNF therapy

- Participants must have had an inadequate response, loss of response, or intolerance to
prior corticosteroid and/or immunosuppressant treatment

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

- Use of highly effective contraception

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

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

- Have received non-permitted inflammatory bowel disease (IBD) therapies (including
natalizumab, vedolizumab, and efalizumab) as stated in the protocol

- Prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion
molecule [MAdCAM-1])

- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), or
tuberculosis (active or latent)
We found this trial at
76
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
1221
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Dallas, TX
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1357
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Houston, TX
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
1352
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Houston, TX
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
2135
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Jacksonville, FL
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
2282
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1511
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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701 West Morse Boulevard
Winter Park, Florida 32789
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Asheville, North Carolina 28801
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Aventura, FL
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Bellevue, Washington 98004
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Belton, Missouri 64012
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Brockton, Massachusetts 02302
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Brownsburg, Indiana
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Chapel Hill, NC
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1215 Lee Street
Charlottesville, Virginia 22908
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30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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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,...
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10123 Alliance Road
Cincinnati, Ohio 45014
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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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Columbia, South Carolina 29203
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Coral Springs, Florida 33071
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3409 Worth Street
Dallas, Texas 75231
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Decatur, Alabama 35601
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1378 Northwest 124th Street
Des Moines, Iowa 50312
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Detroit, Michigan 48202
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Dothan, Alabama 36305
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Germantown, Tennessee 38138
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Homestead, Florida 33030
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LaFayette, Colorado 80026
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Limerick, Pennsylvania 19468
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2080 Century Park East
Los Angeles, California 90067
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Marietta, Georgia 30060
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Miami, Florida 33155
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Miami Beach, Florida 33140
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5000 West National Avenue
Milwaukee, Michigan 53295
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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...
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Miramar, Florida 33025
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Modesto, California 95355
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2630 Grant Line Road
New Albany, Indiana 47150
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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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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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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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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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Saint Louis, Michigan 63122
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30 North 1900 East
Salt Lake City, Utah 84132
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Santa Monica, California 90404
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1221 Madison Street
Seattle, Washington 98104
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7510 Arkansas 107
Sherwood, Arkansas 72120
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Shreveport, Louisiana 71103
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Southfield, Michigan 58304
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505 Nolen Drive
Southlake, Texas 76092
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Towson, Maryland 21204
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Ventura, California 93003
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502 Centennial Boulevard
Voorhees, New Jersey 08043
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