Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
NCT ID: NCT00552058
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2008-03-31
2009-11-30
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
QUADRUPLE
Study Groups
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Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Placebo
Placebo, saline solution for sc injection
Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
Interventions
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certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 - 75 years inclusive
* diagnosis of Crohn's disease confirmed
* moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
* no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Pell City, Alabama, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Winter Park, Florida, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Monroe, Louisiana, United States
Annapolis, Maryland, United States
Towson, Maryland, United States
Chesterfield, Michigan, United States
West Bloomfield, Michigan, United States
Rochester, Minnesota, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Lancaster, Pennsylvania, United States
Germantown, Tennessee, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Concord, New South Wales, Australia
Box Hill, Victoria, Australia
Footscray, Victoria, Australia
Parkville, Victoria, Australia
Adelaide, , Australia
Bankstown, , Australia
Clayton, , Australia
Fitzroy, , Australia
Fremantle, , Australia
Garran, , Australia
Vienna, , Austria
Bonheiden, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Belo Horizonte, Minas Gerais, Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Santo André, , Brazil
Santos, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Calgary, , Canada
Santiago, , Chile
Viña del Mar, , Chile
Hradec Králové, , Czechia
Hradek Kralove, , Czechia
Prague, , Czechia
Ústí nad Orlicí, , Czechia
Zlín, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Mikkeli, , Finland
Berlin, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Homburg, , Germany
Jena, , Germany
Kiel, , Germany
München, , Germany
Ulm, , Germany
Wilhelmshaven, , Germany
Budapest, , Hungary
Győr, , Hungary
Nagykanizsa, , Hungary
Szeged, , Hungary
Szombathely, , Hungary
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petha Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Bologna, , Italy
Padua, , Italy
Roma, , Italy
Riga, , Latvia
Valmiera, , Latvia
Milford, Auckland, New Zealand
Newton, Wellington Region, New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Częstochowa, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Constanța, , Romania
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Dniepropetrovsk, , Ukraine
Donetsk, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
Countries
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References
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Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1.
Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2007-001913-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87085
Identifier Type: -
Identifier Source: org_study_id
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