A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors
- Conditions
- lcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-004280-31-CZ
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
• 18-80 years of age, inclusive.
• Diagnosis of UC established at least 3 months prior to Day 1 by clinical and endoscopic evidence.
• Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
• Naive to treatment with TNF inhibitor therapy
• An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
• Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide therapy, 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 339
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
• 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.
• Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
• 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 maintenance of remission at Week 62 for randomized patients in remission at Week 10;Secondary Objective: • To evaluate maintenance of clinical remission at Week 62 for randomized patients in clinical remission at Week 10<br>• To evaluate clinical remission at Week 62<br>• To evaluate the overall safety and tolerability of etrolizumab over a period of 62 weeks<br>;Primary end point(s): Maintenance of remission among randomized patients in remission at Week 10 as determined by the Mayo Clinic Score (MCS).<br>;Timepoint(s) of evaluation of this end point: Week 62<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Maintenance of clinical remission among randomized patients in clinical remission at Week 10 as determined by MCS.<br>2) Clinical remission as determined by the MCS;Timepoint(s) of evaluation of this end point: 1) Week 62<br>2) Week 62