A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
NCT ID: NCT00279422
Last Updated: 2012-03-12
Study Results
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Basic Information
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TERMINATED
PHASE2/PHASE3
127 participants
INTERVENTIONAL
2006-02-28
2007-08-31
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
QUADRUPLE
Study Groups
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placebo
visilizumab
visilizumab
visilizumab
Interventions
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visilizumab
visilizumab
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
* Severe active disease, as defined by a Modified Truelove \& Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
* Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
* Adequate contraception from the day of consent through 3 months after the last dose of study drug.
* Negative serum pregnancy test.
* Negative Clostridium difficile test.
* Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
Exclusion Criteria
* History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
* Presence of Ileostomy.
* White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin level less than 8 g/dL.
* Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
* Live vaccination within 6 weeks prior to randomization.
* Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
* History of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
* History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
* Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
* Pregnancy or nursing.
* Treatment with a first dose of infliximab or another anti-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
* Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
* Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, immediately prior to randomization.
* Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
* Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
18 Years
ALL
No
Sponsors
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PDL BioPharma, Inc.
INDUSTRY
Facet Biotech
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
San Francisco, California, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
New York, New York, United States
New York, New York, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Galveston, Texas, United States
Camperdown, New South Wales, Australia
Liverpool, New South Wales, Australia
Herston, Queensland, Australia
South Brisbane, Queensland, Australia
Box Hill, Victoria, Australia
Bedford Park, , Australia
Fitzroy, , Australia
Fremantle, , Australia
Parkville, , Australia
Vienna, , Austria
Ghent, , Belgium
Leuven, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
London, Ontario, Canada
Brno, , Czechia
Prague, , Czechia
Amiens, Cedex, France
Clichy, , France
Lille, , France
Marseille, , France
Nantes, , France
Nice, , France
Paris, , France
Berlin, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
Kiel, , Germany
München, , Germany
Rostock, , Germany
Stuttgart, , Germany
Argenti Döme, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Csabai Kapu, , Hungary
Debrecen, , Hungary
Győr, Vasvári Pál, , Hungary
Szekszárd, , Hungary
Veszprém, , Hungary
Haifa, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Oslo, , Norway
Prinsens, , Norway
Tromsø, , Norway
Mickieviczova, , Slovakia
Kharkiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Countries
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References
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Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.
Other Identifiers
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291-415
Identifier Type: -
Identifier Source: org_study_id
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