A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Phase 1

• Conditions: lcerative colitis; MedDRA version: 17.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-004278-88-ES
• Lead Sponsor: Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-13
• Study Completion: 2020-04-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 609

Inclusion Criteria

? 18-80 years of age, inclusive.
? Moderately to severely active ulcerative colitis (UC) as determined by the Mayo Clinic Score assessment (MCS).
? Intolerance, loss of response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years.
? Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period.
? Use of highly effective contraception as defined by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 776
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

-A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis,suspicion of ischemic colitis,radiation colitis, or microscopic 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.
-Chronic hepatitis B or C infection, HIV, or tuberculosis (active or latent).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified