Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11150%2F17%3A10363688" target="_blank" >RIV/00216208:11150/17:10363688 - isvavai.cz</a>
Alternative codes found
RIV/00179906:_____/17:10363688
Result on the web
<a href="http://dx.doi.org/10.1016/S0140-6736(17)30930-3" target="_blank" >http://dx.doi.org/10.1016/S0140-6736(17)30930-3</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S0140-6736(17)30930-3" target="_blank" >10.1016/S0140-6736(17)30930-3</a>
Alternative languages
Result language
angličtina
Original language name
Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial
Original language description
Background PF-00547659 is a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) to selectively reduce lymphocyte homing to the intestinal tract. We aimed to assess the efficacy and safety of PF-00547659 in patients with moderate to severe ulcerative colitis. Methods This phase 2, randomised, double-blind, placebo-controlled clinical trial recruited patients aged 18-65 years from 105 centres in 21 countries, with a history (>= 3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score >= 6 and a Mayo endoscopic subscore >= 2) who had failed or were intolerant to at least one conventional therapy. Patients were stratified by previous anti-TNF alpha treatment, and randomly assigned by a computer-generated randomisation schedule to receive a subcutaneous injection of 7.5 mg, 22.5 mg, 75 mg, or 225 mg PF-00547659 or placebo at baseline, then every 4 weeks. Patients, investigators, and sponsors were blinded to the treatment. The primary endpoint was the proportion of patients achieving remission (total Mayo score <= 2 with no individual subscore >1 and rectal bleeding subscore <= 1) at week 12. The efficacy analysis included all patients who received at least one dose of the randomised treatment; the safety analysis was done according to treatment received. All p values were one-sided and multiplicity-adjusted. This study is registered with ClinicalTrials.gov, number NCT01620255.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30219 - Gastroenterology and hepatology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
The Lancet
ISSN
0140-6736
e-ISSN
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Volume of the periodical
390
Issue of the periodical within the volume
10090
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
135-144
UT code for WoS article
000404976600030
EID of the result in the Scopus database
2-s2.0-85019363567