Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
NCT ID: NCT01336465
Last Updated: 2016-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2011-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rhuMAb Beta7
rhuMAb Beta7
Repeating subcutaneous injection
placebo
placebo
Repeating subcutaneous injection
Interventions
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placebo
Repeating subcutaneous injection
rhuMAb Beta7
Repeating subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Disease duration at time of screening of \>/= 12 weeks
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon O'Byrne, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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San Diego, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Chevy Chase, Maryland, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Great Neck, New York, United States
Cincinnati, Ohio, United States
Garran, Australian Capital Territory, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Bonheiden, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
London, Ontario, Canada
Woodbridge, Ontario, Canada
Hradec Králové, , Czechia
Náchod, , Czechia
Ostrava - Poruba, , Czechia
Zlín, , Czechia
Berlin, , Germany
Hanover, , Germany
Kiel, , Germany
Minden, , Germany
Ulm, , Germany
Budapest, , Hungary
Budapest, , Hungary
Gyöngyös, , Hungary
Győr, , Hungary
Mosonmagyaróvár, , Hungary
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Takapuna, , New Zealand
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Harrow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9.
Other Identifiers
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GP27778
Identifier Type: OTHER
Identifier Source: secondary_id
ABS4986g
Identifier Type: -
Identifier Source: org_study_id
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