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Randomised clinical trial: vercirnon, an oral CCR9 antagonist, vs. placebo as induction therapy in active Crohn's disease.

Identifieur interne : 002764 ( PubMed/Checkpoint ); précédent : 002763; suivant : 002765

Randomised clinical trial: vercirnon, an oral CCR9 antagonist, vs. placebo as induction therapy in active Crohn's disease.

Auteurs : B G Feagan [Canada] ; W J Sandborn [États-Unis] ; G. D'Haens [Pays-Bas] ; S D Lee [États-Unis] ; M. Allez [France] ; R N Fedorak [Canada] ; U. Seidler [Allemagne] ; S. Vermeire [Belgique] ; I C Lawrance [Australie] ; A C Maroney [États-Unis] ; C H Jurgensen [États-Unis] ; A. Heath [États-Unis] ; D J Chang [États-Unis]

Source :

RBID : pubmed:26400458

Descripteurs français

English descriptors

Abstract

Many patients with active Crohn's disease do not adequately respond to therapies, highlighting the need for new treatments.

DOI: 10.1111/apt.13398
PubMed: 26400458


Affiliations:


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pubmed:26400458

Le document en format XML

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<name sortKey="Lawrance, I C" sort="Lawrance, I C" uniqKey="Lawrance I" first="I C" last="Lawrance">I C Lawrance</name>
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<term>Adult</term>
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<term>Crohn Disease (drug therapy)</term>
<term>Double-Blind Method</term>
<term>Feces</term>
<term>Female</term>
<term>Humans</term>
<term>Leukocyte L1 Antigen Complex (metabolism)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Receptors, CCR (antagonists & inhibitors)</term>
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<term>Fèces</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Maladie de Crohn (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Protéine C-réactive (métabolisme)</term>
<term>Récepteurs CCR (antagonistes et inhibiteurs)</term>
<term>Sulfonamides (usage thérapeutique)</term>
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<term>Receptors, CCR</term>
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<term>C-Reactive Protein</term>
<term>Leukocyte L1 Antigen Complex</term>
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<term>Crohn Disease</term>
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<term>Complexe antigénique L1 leucocytaire</term>
<term>Protéine C-réactive</term>
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<term>Maladie de Crohn</term>
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<term>Sulfonamides</term>
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<term>Adult</term>
<term>Double-Blind Method</term>
<term>Feces</term>
<term>Female</term>
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<term>Young Adult</term>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Fèces</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
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<div type="abstract" xml:lang="en">Many patients with active Crohn's disease do not adequately respond to therapies, highlighting the need for new treatments.</div>
</front>
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<DateCreated>
<Year>2015</Year>
<Month>10</Month>
<Day>09</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>05</Month>
<Day>05</Day>
</DateCompleted>
<DateRevised>
<Year>2015</Year>
<Month>10</Month>
<Day>09</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1365-2036</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>42</Volume>
<Issue>10</Issue>
<PubDate>
<Year>2015</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>Alimentary pharmacology & therapeutics</Title>
<ISOAbbreviation>Aliment. Pharmacol. Ther.</ISOAbbreviation>
</Journal>
<ArticleTitle>Randomised clinical trial: vercirnon, an oral CCR9 antagonist, vs. placebo as induction therapy in active Crohn's disease.</ArticleTitle>
<Pagination>
<MedlinePgn>1170-81</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1111/apt.13398</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Many patients with active Crohn's disease do not adequately respond to therapies, highlighting the need for new treatments.</AbstractText>
<AbstractText Label="AIMS" NlmCategory="OBJECTIVE">To conduct a randomised, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of vercirnon, an oral inhibitor of CC chemokine receptor-9, for the treatment of patients with moderately-to-severely active Crohn's disease.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients with a Crohn's Disease Activity Index (CDAI) of 220-450, plus evidence of active disease (endoscopically confirmed or elevation of both C-reactive protein and faecal calprotectin), who had failed corticosteroid or immunosuppressant therapy were enrolled. Patients were equally randomised to receive placebo, vercirnon 500 mg once daily or vercirnon 500 mg twice daily. The primary endpoint was clinical response, defined as a 100-point decrease in CDAI from baseline to week 12.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Six hundred and eight patients were randomised. Patient characteristics and baseline demographics were similar among the groups. The proportions of patients achieving a clinical response were 25.1%, 27.6% and 27.2% for placebo, once daily and twice daily respectively; treatment differences were not significant (2.5%; 95% confidence interval, CI -6.1% to 11.0%, P = 0.546 for once daily vs. placebo, and 2.1%; 95% CI -6.5% to 10.7%, P = 0.648 for twice daily vs. placebo). Adverse events were reported in 69.8%, 73.3% and 78.1% with serious adverse events in 8.9%, 5.9%, and 6.0% of patients in the placebo, once-daily and twice-daily groups, respectively.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">We did not demonstrate efficacy of vercirnon as an induction therapy in patients with moderately-to-severely active Crohn's disease; its effect in maintenance therapy was not addressed.</AbstractText>
<CopyrightInformation>© 2015 John Wiley & Sons Ltd.</CopyrightInformation>
</Abstract>
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<LastName>Feagan</LastName>
<ForeName>B G</ForeName>
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