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- GARDENIA
A Clinical Trial to Compare Etrolizumab with Infliximab in Patients with Moderate to Severe Ulcerative Colitis Who Have not Received Treatment with Tumour Necrosis Factor Inhibitors (Gardenia)
Phase III, randomized, multicenter double-blind, double dummy study to evaluate the efficacy and safety of Etrolizumab compared with Infliximab in patients with moderate to severe active Ulcerative Colitis who are naïve to TNF inhibitors
Autoimmune Disorder Inflammatory Bowel Disease (IBD) Ulcerative Colitis
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT02136069, GA29103, 2013-004282-14
Condition
Ulcerative Colitis
Official Title
Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Study Summary
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
Eligibility Criteria
All
≥ 18 Years & ≤ 80 Years
No
Inclusion Criteria
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)
- An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
- Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
- Use of highly effective contraception during and at least 24 weeks after the last dose of study drug
Exclusion Criteria
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation 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, efalizumab, and tofactinib)
- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
- Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com