Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
This study has been completed.
Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01336465
First received: April 14, 2011
Last updated: February 4, 2015
Last verified: February 2015
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Purpose
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 Blind (Subject, 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:
Genetics Home Reference related topics:
ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]
| 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: A |
Drug: rhuMAb Beta7
Repeating subcutaneous injection
|
| Placebo Comparator: B |
Drug: placebo
Repeating subcutaneous injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
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 ClinicalTrials.gov identifier: NCT01336465
Show 51 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336465
Show 51 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Sharon O'Byrne, M.D. | Genentech, Inc. |
More Information
No publications provided by Genentech, Inc.
Additional 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 |
| Study First Received: | April 14, 2011 |
| Last Updated: | February 4, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colitis, Ulcerative Ulcer Colitis Colonic Diseases Digestive System Diseases |
Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2015