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.
- Conditions
- lcerative colitisMedDRA version: 18.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-004278-88-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
• 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
• 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 placebo for the induction of remission in patients with ulcerative colitis at Week 14.<br>• To evaluate the efficacy of etrolizumab compared with placebo for maintenance of remission at Week 66 for randomized patients in remission at Week 14<br>;Secondary Objective: • To evaluate induction of clinical remission at Week 14<br>• To evaluate maintenance of clinical remission at Week 66 in patients in clinical remission at Week 14<br>• To evaluate the overall safety and tolerability of etrolizumab compared with placebo during induction and maintenance therapy over a period of 66 weeks<br>;Primary end point(s): 1) Remission as determined by the Mayo Clinic Score (MCS).<br>2) Remission maintenance among patients with remission at Week 14. Measured by MCS.<br>;Timepoint(s) of evaluation of this end point: 1) at week 14 <br>2) at week 66
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Clinical remission as determined by MCS.;Timepoint(s) of evaluation of this end point: At week 14 and 66