Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: placebo Drug: rhuMAb Beta7 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: rhuMAb Beta7 |
Drug: rhuMAb Beta7
Repeating subcutaneous injection |
Placebo Comparator: placebo |
Drug: placebo
Repeating subcutaneous injection |
- Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 10 ]
- 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 ]

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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 |
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

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

Study Director: | Sharon O'Byrne, M.D. | Genentech, Inc. |
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 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |
Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Etrolizumab Gastrointestinal Agents Immunologic Factors Physiological Effects of Drugs |