Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00179906:_____/17:10363688

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial

Popis výsledku v původním jazyce

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 (&gt;= 3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score &gt;= 6 and a Mayo endoscopic subscore &gt;= 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 &lt;= 2 with no individual subscore &gt;1 and rectal bleeding subscore &lt;= 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.

Název v anglickém jazyce

Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial

Popis výsledku anglicky

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 (&gt;= 3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score &gt;= 6 and a Mayo endoscopic subscore &gt;= 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 &lt;= 2 with no individual subscore &gt;1 and rectal bleeding subscore &lt;= 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

The Lancet

ISSN

0140-6736

e-ISSN

—

Svazek periodika

390

Číslo periodika v rámci svazku

10090

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

135-144

Kód UT WoS článku

000404976600030

EID výsledku v databázi Scopus

2-s2.0-85019363567