Determining the optimal treatment target in patients with ulcerative colitis : rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC.
METHODS AND ANALYSIS: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model.
ETHICS AND DISSEMINATION: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings.
TRIAL REGISTRATION NUMBER: EudraCT: 2019-002485-12; NCT04259138.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
BMJ open gastroenterology - 11(2024), 1 vom: 08. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jairath, Vipul [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial Protocol |
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| Anmerkungen: |
Date Completed 14.02.2024 Date Revised 18.02.2024 published: Electronic ClinicalTrials.gov: NCT04259138 Citation Status MEDLINE |
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| doi: |
10.1136/bmjgast-2023-001218 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Determining the optimal treatment target in patients with ulcerative colitis |b rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC | ||
| 520 | |a METHODS AND ANALYSIS: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model | ||
| 520 | |a ETHICS AND DISSEMINATION: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings | ||
| 520 | |a TRIAL REGISTRATION NUMBER: EudraCT: 2019-002485-12; NCT04259138 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ENDOSCOPY | |
| 650 | 4 | |a HISTOPATHOLOGY | |
| 650 | 4 | |a ULCERATIVE COLITIS | |
| 700 | 1 | |a Zou, Guangyong |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zhongya |e verfasserin |4 aut | |
| 700 | 1 | |a Adsul, Shashi |e verfasserin |4 aut | |
| 700 | 1 | |a Colombel, Jean-Frederic |e verfasserin |4 aut | |
| 700 | 1 | |a D'Haens, Geert R |e verfasserin |4 aut | |
| 700 | 1 | |a Freire, Marcelo |e verfasserin |4 aut | |
| 700 | 1 | |a Moran, Gordon W |e verfasserin |4 aut | |
| 700 | 1 | |a Peyrin-Biroulet, Laurent |e verfasserin |4 aut | |
| 700 | 1 | |a Sandborn, William J |e verfasserin |4 aut | |
| 700 | 1 | |a Sebastian, Shaji |e verfasserin |4 aut | |
| 700 | 1 | |a Travis, Simon |e verfasserin |4 aut | |
| 700 | 1 | |a Vermeire, Séverine |e verfasserin |4 aut | |
| 700 | 1 | |a Radulescu, Gabriela |e verfasserin |4 aut | |
| 700 | 1 | |a Sigler, Julie |e verfasserin |4 aut | |
| 700 | 1 | |a Hanžel, Jurij |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Sedano, Rocio |e verfasserin |4 aut | |
| 700 | 1 | |a McFarlane, Stefanie C |e verfasserin |4 aut | |
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| 700 | 1 | |a Beaton, Melanie |e verfasserin |4 aut | |
| 700 | 1 | |a Bossuyt, Peter |e verfasserin |4 aut | |
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| 700 | 1 | |a Green, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Harlan, William |c 3rd |e verfasserin |4 aut | |
| 700 | 1 | |a Horynski, Marek |e verfasserin |4 aut | |
| 700 | 1 | |a Klopocka, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Petroniene, Rima |e verfasserin |4 aut | |
| 700 | 1 | |a Silverberg, Mark S |e verfasserin |4 aut | |
| 700 | 1 | |a Wolanski, Lukasz |e verfasserin |4 aut | |
| 700 | 1 | |a Feagan, Brian G |e verfasserin |4 aut | |
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