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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):

Study Description
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

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
Primary Completion Date : September 2012
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

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


  Hide Study Locations
Locations
United States, California
San Diego, California, United States, 92103
United States, Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Maryland
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0682
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Great Neck, New York, United States, 11021
United States, Ohio
Cincinnati, Ohio, United States, 45219
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, Victoria
Clayton, Victoria, Australia, 3168
Fitzroy, Victoria, Australia, 3065
Melbourne, Victoria, Australia, 3181
Parkville, Victoria, Australia, 3050
Belgium
Bonheiden, Belgium, 2820
Gent, Belgium, 9000
Leuven, Belgium, 3000
Liège, Belgium, 4000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2X8
Edmonton, Alberta, Canada, V6Z 1Y6
Canada, Ontario
London, Ontario, Canada, N6A 5W9
Woodbridge, Ontario, Canada, L4L 4Y7
Czech Republic
Hradec Kralove, Czech Republic, 500 12
Nachod, Czech Republic, 547 01
Ostrava - Poruba, Czech Republic, 708 52
Zlin, Czech Republic, 762 75
Germany
Berlin, Germany, 13353
Hannover, Germany, 30625
Kiel, Germany, 24105
Minden, Germany, 32423
Ulm, Germany, 89081
Hungary
Budapest, Hungary, 1073
Budapest, Hungary, 1136
Gyor, Hungary, 9024
Gyöngyös, Hungary, 3200
Mosonmagyaróvár, Hungary, 9200
Israel
Beer Sheva, Israel, 84105
Haifa, Israel, 31096
Jerusalem, Israel, 91031
Ramat Gan, Israel, 52621
Tel Aviv, Israel, 64239
New Zealand
Auckland, New Zealand, 1023
Auckland, New Zealand, 1640
Christchurch, New Zealand, 8011
Dunedin, New Zealand, 9054
Takapuna, New Zealand, 0620
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08036
United Kingdom
Harrow, United Kingdom, HA1 3UJ
London, United Kingdom, N6A 4L6
London, United Kingdom, SW10 9NH
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Sharon O'Byrne, M.D. Genentech, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01336465     History of Changes
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:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases