Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2006-02-28
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg
Certolizumab pegol
Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
Interventions
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Certolizumab pegol
Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy
Exclusion Criteria
* History of tuberculosis or positive tests for tuberculosis at screening
* All the 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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Bonheiden, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Amiens, , France
Besançon, , France
Chambray-lès-Tours, , France
Clichy, , France
Grenoble, , France
Lille, , France
Marseille, , France
Nice, , France
Paris, , France
Reims, , France
Rouen, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Bonn, , Germany
Countries
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References
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Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hebuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1.
Hebuterne X, Lemann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault E, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EudraCT Number 2005-003977-25
Identifier Type: OTHER
Identifier Source: secondary_id
C87043
Identifier Type: -
Identifier Source: org_study_id