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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: April 14, 2011
Last updated: August 10, 2016
Last verified: August 2016
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 Intervention Phase
Ulcerative Colitis Drug: placebo Drug: rhuMAb Beta7 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

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

Secondary Outcome Measures:
  • 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 ]
  • Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ]
  • Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ]

Enrollment: 124
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhuMAb Beta7 Drug: rhuMAb Beta7
Repeating subcutaneous injection
Placebo Comparator: placebo Drug: placebo
Repeating subcutaneous injection


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01336465

  Hide Study 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
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
Berlin, Germany, 13353
Hannover, Germany, 30625
Kiel, Germany, 24105
Minden, Germany, 32423
Ulm, Germany, 89081
Budapest, Hungary, 1073
Budapest, Hungary, 1136
Gyor, Hungary, 9024
Gyöngyös, Hungary, 3200
Mosonmagyaróvár, Hungary, 9200
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
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.
Study Director: Sharon O'Byrne, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Genentech, Inc. Identifier: NCT01336465     History of Changes
Other Study ID Numbers: ABS4986g
GP27778 ( Other Identifier: Hoffmann-La Roche )
Study First Received: April 14, 2011
Last Updated: August 10, 2016

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases processed this record on September 19, 2017