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 colitis (UC)MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-004280-31-PL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- 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)
• Evidence of UC extending a minimum of 20 cm from the anal verge as
determined by baseline endoscopy
• Naive to treatment with any anti-TNF therapy
•Patients must have an inadequate response, loss of response, or
intolerance to prior corticosteroid and/or immunosuppressant treatment
• Background regimen for UC may include oral 5-aminosalicylic acid (5-
ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-
mercaptopurine (6-MP), or methotrexate (MTX) if doses have been
stable during the screening period
• Use of highly effective contraception as defined by the protocol
• Must have received a colonoscopy within the past year or be willing to
undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
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)
- Any prior treatment with rituximab
- Any treatment with tofacitinib during screening
- Congenital or acquired immune deficiency, chronic hepatitis B or C
infection, Human Immunodeficiency Virus (HIV) positive, or history of
tuberculosis (active or latent)
- Evidence of or treatment for Clostridium difficile within 60 days prior to
Day 1 or other intestinal pathogens within 30 days prior to Day 1
- History of recurrent opportunistic infections, severe disseminated viral
infections and organ transplant
- Any major episode of infection requiring treatment with intravenous
(IV) antibiotics within 8 weeks Prior to screening or oral antibiotics
within 4 weeks prior to screening
- Received a live attenuated vaccine within 4 weeks prior to Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method