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A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors

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Disease Information

Descriptive Information
Brief Title † A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors
Official Title † 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 Are Refractory to or Intolerant of TNF Inhibitors
Brief Summary 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 are refractory to or intolerant of TNF inhibitors.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)
Secondary Outcome Measure † Percentage of Participants With Clinical Remission at Week 14 (Induction Phase) and Week 66 (Maintenance Phase), as Determined by MCS
Condition † Ulcerative Colitis
Intervention † DrugEtrozulimab
Study Arms / Comparison Groups Cohort 1: Etrolizumab (Open-label Induction Phase) All participants will receive treatment with open-label etrolizumab 105 milligram (mg) subcutaneous injection every 4 weeks for 14 weeks. Cohort 2: Etrolizumab (Double-blind Induction Phase) All participants will receive treatment with etrolizumab 105 mg subcutaneous injection every 4 weeks for 14 weeks. Cohort 2: Placebo (Double-blind Induction Phase) All participants will receive treatment with placebo matched with etrolizumab. Etrolizumab (Maintenance Phase) Participants who achieved a clinical response at Week 14 during induction phase (etrolizumab open-label and double blind arm) and randomized to this arm will receive etrolizumab 105 mg subcutaneous injection every 4 weeks up to week 66. Placebo (Maintenance Phase) Participants who achieved a clinical response at Week 14 during induction phase (etrolizumab open-label and double blind arm, placebo double blind arm) and are randomized to this arm will receive placebo matched to etrolizumab.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 800
Start Date † May 31, 2014
Completion Date January 9, 2019
Primary Completion Date January 9, 2019
Eligibility Criteria † Inclusion Criteria: - Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS) - Intolerance, loss response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years - 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 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 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 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 - 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
Gender All
Ages 18 Years - 80 Years
Accepts Healthy Volunteers No
Contacts †† Reference Study ID Number: GA28950 www.roche.com/about_roche/roche_worldwide.htm, 888-662-6728 (U.S. and Canada), global.rochegenentechtrials@roche.com
Location Countries † Argentina
Administrative Information
NCT ID † NCT02100696
Organization ID GA28950
Secondary IDs †† 2013-004278-88
Responsible Party Sponsor
Study Sponsor † Hoffmann-La Roche
Collaborators ††
Investigators † Study Director: Clinical Trials, Hoffmann-La Roche
Information Provided By
Verification Date June 2017
First Received Date † March 27, 2014
Last Updated Date June 12, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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