A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received 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: EUCTR2013-004282-14-NO
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-04
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

- 18-80 years of age, inclusive.
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- Naive to treatment with any anti-TNF therapy
- An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
- 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 698
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of etrolizumab compared with infliximab for sustained remission at Weeks 10, 30, and 54 in patients with ulcerative colitis;Secondary Objective: • To evaluate remission at Week 10<br>• To evaluate remission at Week 54<br>• To evaluate sustained clinical remission at Weeks 10, 30, and 54<br>• To evaluate clinical response at Week 10.<br>• To evaluate sustained clinical response at Weeks 10, 30 and 54.<br>• To evaluate clinical remission at Week 54.<br>• To evaluate the overall safety and tolerability of etrolizumab over a period of 54 weeks.<br>;Primary end point(s): Sustained remission as determined by Mayo clinic score (MCS);Timepoint(s) of evaluation of this end point: At Weeks 10, 30, and 54

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Remission <br>2) Clinical remission <br>3) Sustained clinical remission <br>4) Sustained clinical response<br>5) Clinical response<br>;Timepoint(s) of evaluation of this end point: 1) Weeks 10 and 54<br>2) week 54<br>3) Weeks 10, 30 and 54<br>4) Weeks 10, 30 and 54<br>5) week 10<br>