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 |
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.
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
sites
Click here to add this to my saved trials
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
Click here to add this to my saved trials
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
Click here to add this to my saved trials
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Click here to add this to my saved trials
1215 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
Click here to add this to my saved trials
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
Click here to add this to my saved trials
Click here to add this to my saved trials
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
San Francisco, California 94158
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
908 Jefferson Street
Seattle, Washington 98104
Seattle, Washington 98104
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials