Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
NCT ID: NCT00308581
Last Updated: 2018-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
539 participants
INTERVENTIONAL
2006-04-30
2008-04-30
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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Active 1
Q4W regimen
\- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Placebo
placebo administered 4-weekly in Active 1
Active 2
Q2W regimen
\- every 2 weeks: 400 mg Certolizumab Pegol
Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Interventions
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Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Placebo
placebo administered 4-weekly in Active 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous treatment failure to Infliximab (intolerance and/or no response)
Exclusion Criteria
* Recent bowel resection
* Proctocolectomy or total colectomy
* Current total parenteral nutrition
* Short bowel syndrome
* All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
18 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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San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Lincoln, Nebraska, United States
Great Neck, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Innsbruck, , Austria
Oberpullendorf, , Austria
Vienna, , Austria
Bonheiden, , Belgium
Brussels, , Belgium
Genk, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Richmond, Ontario, Canada
Toronto, Ontario, Canada
Calgary, , Canada
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Herlev, , Denmark
Amiens, , France
Clichy, , France
Grenoble, , France
Lille, , France
Montpellier, Cédex 5, , France
Nice, , France
Paris, , France
Pessac, , France
Rouen, , France
Toulouse, , France
Berlin, , Germany
Hamburg, , Germany
Hanover, , Germany
Herne, , Germany
Kiel, , Germany
Leipzig, , Germany
Minden, , Germany
Munich, , Germany
München, , Germany
Bari, , Italy
Bologna, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Roma, , Italy
Torino, , Italy
Amsterdam, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Heerlen, , Netherlands
Leiden, , Netherlands
Terneuven, , Netherlands
Zwolle, , Netherlands
Oslo, , Norway
Tromsø, , Norway
Barcelona, , Spain
Madrid, , Spain
Oviedo, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Lausanne, , Switzerland
Bristol, , United Kingdom
Cambridge, , United Kingdom
Edinburgh, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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Eudract number: 2005-004104-37
Identifier Type: -
Identifier Source: secondary_id
C87042
Identifier Type: -
Identifier Source: org_study_id
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