A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-004282-14-AT
• 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: 2014-07-22
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

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 Inhibitor 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, 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
- 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 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Prior extensive colonic resection, subtotal or total colectomy, or
planned surgery for UC
- A history of or current conditions and diseases affecting the digestive
tract, such as ileostomy or colostomy 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
- Have received non-permitted inflammatory bowel disease (IBD)
therapies (including etrolizumab or other anti-integrin agents such as
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
- History of moderate or severe allergic or anaphylactic/anaphylactoid
reactions to chimeric, human, or humanized antibodies, fusion proteins or murine proteins or hypersensitivity to etrolizumab or any of the excipients
- Neurologic conditions or diseases that may interfere with monitoring
for PML
- History of demyelinating disease
- Clinically significant abnormalities on screening neurologic examination (PML Objective/Subjective Checklists)
- History of cancer, including hematologic malignancy, solid tumors, and carcinoma in situ, within 5 years before screening, as defined by the protocol
- Congenital or acquired immune deficiency, chronic hepatitis B or C
infection, HIV positive or history of tuberculosis (active or latent)
- Evidence of or treatment for Clostridium difficile (as assessed by C.
difficile toxin testing) within 60 days prior to Day 1 or other intestinal
pathogens within 30 days prior to Day 1.
- Evidence of or treatment for clinically significant cytomegalovirus
(CMV) colitis within 60 days prior to Day 1.
- History of recurrent opportunistic infections and/or history of severe
disseminated viral infections, or organ transplant
- Any serious opportunistic infection within the last 6 months
- Any major episode of infection requiring treatment with 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