2007
DOI: 10.1056/nejmoa067594
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Certolizumab Pegol for the Treatment of Crohn's Disease

Abstract: In patients with moderate-to-severe Crohn's disease, induction and maintenance therapy with certolizumab pegol was associated with a modest improvement in response rates, as compared with placebo, but with no significant improvement in remission rates. (ClinicalTrials.gov number, NCT00152490 [ClinicalTrials.gov].).

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Cited by 1,024 publications
(703 citation statements)
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“…Since the first double-blind, placebo-controlled trial with Infliximab (IFX) 2 numerous pivotal trials on the efficacy of IFX, Adalimumab (ADA) and Certzolizumab pegol (CTZ) in inducing and maintaining clinical response and remission and achieving mucosal healing have been published [2][3][4][5][6][7] .…”
Section: Introductionmentioning
confidence: 99%
“…Since the first double-blind, placebo-controlled trial with Infliximab (IFX) 2 numerous pivotal trials on the efficacy of IFX, Adalimumab (ADA) and Certzolizumab pegol (CTZ) in inducing and maintaining clinical response and remission and achieving mucosal healing have been published [2][3][4][5][6][7] .…”
Section: Introductionmentioning
confidence: 99%
“…Patients who completed either of the PRECiSE 1 or 2 studies (which began in December 2003 and February 2004 respectively 18,19 ) were eligible for enrolment in the long-term extension study, PRECiSE 3 (ClinicalTrials.gov identifier NCT00160524), which continued until August 2012. For eligible patients, enrolment into the PRECiSE 3 study was based on individual patient decision and did not involve the study sponsor.…”
Section: Patientsmentioning
confidence: 99%
“…Enrolment criteria for PRECiSE 1 and 2 (initial studies) have been previously described. 18,19 Briefly, patients were ≥18 years of age and diagnosed with moderate-to-severe CD [Crohn's Disease Activity Index (CDAI) of 220-450 points scored over the week prior to the first study dose, suggesting a failure of conventional treatments]. Approximately 20% of patients were previously treated with, and had responded to, infliximab.…”
Section: Patientsmentioning
confidence: 99%
“…Humanization in theory may lead to a lower frequency of developing antidrug antibodies [59]. Certolizumab pegol is approved for use in Crohn's disease to achieve induction and maintenance of symptomatic response and improvement of quality-of-life measures [60][61][62][63][64][65][66]. Certolizumab pegol may differ from other TNFa antibodies since, due to its structure, it does not induce apoptosis in monocytes.…”
Section: Currently Available Therapeutic Antibodies In Digestive Disementioning
confidence: 99%