Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
NCT ID: NCT00152425
Last Updated: 2013-09-09
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
PHASE3
392 participants
INTERVENTIONAL
2004-02-29
2005-05-31
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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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Certolizumab Pegol (CDP870)
Eligibility Criteria
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Inclusion Criteria
* Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
* Patients aged 18 years or above at screening.
Exclusion Criteria
* Fistula abscess present at screening.
* Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
* Short bowel syndrome.
* Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
* Positive stool laboratory results for enteric pathogens.
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
References
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Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OO, Hanauer SB, McColm J, Bloomfield R, Sandborn WJ; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):239-50. doi: 10.1056/NEJMoa062897.
Feagan BG, Reilly MC, Gerlier L, Brabant Y, Brown M, Schreiber S. Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate-to-severe Crohn's disease in the PRECiSE 2 study. Aliment Pharmacol Ther. 2010 Jun;31(12):1276-85. doi: 10.1111/j.1365-2036.2010.04303.x. Epub 2010 Mar 18.
Lichtenstein GR, Thomsen OO, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, Sandborn WJ; Precise 3 Study Investigators. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol. 2010 Jul;8(7):600-9. doi: 10.1016/j.cgh.2010.01.014. Epub 2010 Feb 1.
Hanauer SB, Panes J, Colombel JF, Bloomfield R, Schreiber S, Sandborn WJ. Clinical trial: impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn's disease. Aliment Pharmacol Ther. 2010 Aug;32(3):384-93. doi: 10.1111/j.1365-2036.2010.04360.x. Epub 2010 May 18.
Feagan BG, Coteur G, Tan S, Keininger DL, Schreiber S. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn's disease. Am J Gastroenterol. 2009 Aug;104(8):1976-83. doi: 10.1038/ajg.2009.199. Epub 2009 May 26.
Coteur G, Feagan B, Keininger DL, Kosinski M. Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn's disease. Aliment Pharmacol Ther. 2009 May 1;29(9):1032-41. doi: 10.1111/j.1365-2036.2009.03966.x.
Feagan BG, Hanauer SB, Coteur G, Schreiber S. Evaluation of a daily practice composite score for the assessment of Crohn's disease: the treatment impact of certolizumab pegol. Aliment Pharmacol Ther. 2011 May;33(10):1143-51. doi: 10.1111/j.1365-2036.2011.04636.x. Epub 2011 Mar 28.
Schreiber S, Lawrance IC, Thomsen OO, Hanauer SB, Bloomfield R, Sandborn WJ. Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease - subgroup results from a placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(2):185-93. doi: 10.1111/j.1365-2036.2010.04509.x. Epub 2010 Nov 17.
Lewis JD. Anti-TNF antibodies for Crohn's disease--in pursuit of the perfect clinical trial. N Engl J Med. 2007 Jul 19;357(3):296-8. doi: 10.1056/NEJMe078111. No abstract available.
Other Identifiers
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C87032
Identifier Type: -
Identifier Source: org_study_id