Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial

Jairath, V; Zou, G; Wang, Z; Adsul, S; Colombel, J-F; D’Haens, GR; Freire, M; Moran, GW; Peyrin-Biroulet, L; Sandborn, WJ; Sebastian, S; Travis, S; Vermeire, S; Radulescu, G; Sigler, J; Hanžel, J; Ma, C; Sedano, R; McFarlane, SC; Arya, N; Beaton, M; Bossuyt, P; Danese, S; Green, D; Harlan, W

Journal article

Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial

Abstract:: 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

Publication status:: Published

Peer review status:: Peer reviewed

Actions

Email

Email this record

Send the bibliographic details of this record to your email address.

Your Email
Please enter the email address that the record information will be sent to.

-
Your message (optional)
Please add any additional information to be included within the email.
Share
Cite

Cite this record

APA Style

Jairath, V., Zou, G., Wang, Z., Adsul, S., Colombel, J.-F., D’Haens, G. R., Freire, M., Moran, G. W., Peyrin-Biroulet, L., Sandborn, W. J., Sebastian, S., Travis, S., Vermeire, S., Radulescu, G., Sigler, J., Hanžel, J., Ma, C., Sedano, R., McFarlane, S. C., … Harlan, W. (2024). Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterology, 11(1), e001218–e001218.

MLA Style

Jairath, V, et al. “Determining the Optimal Treatment Target in Patients with Ulcerative Colitis: Rationale, Design, Protocol and Interim Analysis for the Randomised Controlled VERDICT Trial.” BMJ Open Gastroenterology, vol. 11, no. 1, 2024, pp. e001218–e001218.

Chicago Style

Jairath, V, G Zou, Z Wang, et al. 2024. “Determining the Optimal Treatment Target in Patients with Ulcerative Colitis: Rationale, Design, Protocol and Interim Analysis for the Randomised Controlled VERDICT Trial.” BMJ Open Gastroenterology 11 (1): e001218–e001218.
Print