A study in the use of etrolizumab in patients with ulcerative colitis (Eucalyptus)
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
- Ulcerative Colitis
- Czech Republic
- New Zealand
- United Kingdom
- United States
NCT01336465 GP27778 ABS4986g
Clinical Trial Results
Once the last participant has completed the clinical trial, Roche will analyze the combined results of the trial and create a report summarizing the results. The analysis of the data takes time; however Roche aims to make the summary of the outcome of the clinical trial available within 12 months after the last clinical trial participant has completed the trial. Roche may also provide a summary of trial outcome prior to the end of the clinical trial. Below you can find the available results of the Eucalyptus clinical trial.
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 trial 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 below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.
Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
- Diagnosis of moderate to severe ulcerative colitis outpatient
- Disease duration at time of screening of >/= 12 weeks
- Extensive colonic resection or subtotal or total colectomy
- Presence of an ileostomy or colostomy
- Moderate to severe anemia
- A history or evidence of colonic mucosal dysplasia
- Pregnant or lactating
- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
- Poorly controlled diabetes
- Impaired renal function
- Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
- Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
- Positive screening test for latent mycobacterium tuberculosis (TB) infection
- Demyelinating disease
- Received any investigational treatment within 12 weeks prior to initiation of study treatment
- Previous exposure to rhuMAb Beta7
For the latest version of this information please go to www.forpatients.roche.com