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 |
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.
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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University of Louisville The University of Louisville is a state supported research university located in...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Ann Arbor, Michigan 48109
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191 Biltmore Avenue
Asheville, North Carolina 28801
Asheville, North Carolina 28801
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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303 E Chicago Ave
Chicago, Illinois 60611
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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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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7000 West Colfax Avenue
Lakewood, Colorado 80215
Lakewood, Colorado 80215
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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San Francisco, California 94158
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908 Jefferson Street
Seattle, Washington 98104
Seattle, Washington 98104
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