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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336465
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: placebo Drug: rhuMAb Beta7 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rhuMAb Beta7 Drug: rhuMAb Beta7
Repeating subcutaneous injection
Placebo Comparator: placebo Drug: placebo
Repeating subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 10 ]

Secondary Outcome Measures :
  1. Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1 [ Time Frame: Week 6 and Week 10 ]
  2. Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ]
  3. Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336465


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Sharon O'Byrne, M.D. Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01336465    
Other Study ID Numbers: ABS4986g
GP27778 ( Other Identifier: Hoffmann-La Roche )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
rhuMAb Beta7
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs