Study Comparing the usefulness and safety of Etrolizumab Vs Placebo in patients with Ulcerative Colitis.
Phase 3
- Conditions
- Health Condition 1: null- Patients with moderate to severe active Ulcerative Colitis who wre naive to TNF InhibitorsHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2017/04/008363
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Able and willing to provide written informed consent
Diagnosis of UC established at least 6 months prior
Moderately to severely active UC as determined by an MCS
Evidence of UC extending a minimum of 20 cm from the anal verge
Naive to treatment with any anti-TNF therapy
Exclusion Criteria
Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
Past or present ileostomy or colostomy
Diagnosis of indeterminate colitis
Any prior treatment with etrolizumab or other anti-integrin agents
Pregnant or lactating
Infection Risk
Abnormal Laboratory Values
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission at Week 62 among randomized patients in remission at Week 10Timepoint: Remission at Week 62 among randomized patients in remission at Week 10
- Secondary Outcome Measures
Name Time Method Clinical remission at Week 62 among randomized patients in clinical remission at <br/ ><br>Week 10 <br/ ><br>Clinical remission at Week 62 <br/ ><br>Clinical response at Week 62 <br/ ><br>Improvement in endoscopic appearance of the mucosa at Week 62 <br/ ><br>Endoscopic remission at Week 62Timepoint: Specified above