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

  • Autoimmune Disorder
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Australia
  • Belgium
  • Canada
  • Czech Republic
  • Germany
  • Hungary
  • Israel
  • New Zealand
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT01336465 GP27778 ABS4986g

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      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.

      Results Disclaimer

      Trial Summary

      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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT01336465,ABS4986g,GP27778 Trial Identifier
      placebo, rhuMAb Beta7 Treatments
      Ulcerative Colitis Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of moderate to severe ulcerative colitis outpatient
      • Disease duration at time of screening of >/= 12 weeks
      Exclusion Criteria
      • 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

       

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