Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis



Status:Completed
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:September 2011
End Date:June 2013

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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

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.


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
We found this trial at
8
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Rochester, MN
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Ann Arbor, MI
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Chevy Chase, MD
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Cincinnati, OH
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Gainesville, FL
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Great Neck, NY
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San Diego, CA
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