ArticleClinical and experimental gastroenterology2024
Magnetic Resonance Enterography Assessment of Transmural Healing with Vedolizumab in Moderate to Severe Crohn's Disease: Feasibility in the VERSIFY Phase 3 Clinical Trial.
Article in Clinical and experimental gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02425111 (An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective.United European gastroenterology journal · 2024Pooled it
- Raising the Bar in Crohn's Disease: Is Transmural Healing Achievable?Diagnostics (Basel, Switzerland) · 2026Review
- Imaging endpoints in inflammatory bowel disease: current evidence and future directions for ultrasound and MRI.BMC medicine · 2026Review
- From Conventional Therapy to Precision Medicine in Inflammatory Bowel Disease: A State-of-the-Art Review.Biomedicines · 2026Review
- Evaluating treatment to a target of transmural healing in patients with moderately to severely active Crohn's disease: rationale, design and protocol for the randomised controlled VECTORS trial.BMJ open gastroenterology · 2026Article
- Comparing the accuracy of computed tomography enterography to balloon-assisted enteroscopy in the evaluation of small bowel Crohn's disease.Journal of the Canadian Association of Gastroenterology · 2026Article
- A decade of clinical data with vedolizumab: the past, present, and future.Therapeutic advances in gastroenterology · 2026Review
- Artificial Intelligence-Enabled Clinical Trials in Inflammatory Bowel Disease: Automating and Enhancing Disease Assessment and Study Management.Gastroenterology · 2025Review
- A Guide to the Patient-Centric Use of Vedolizumab for Crohn's Disease.Inflammatory bowel diseases · 2025Review
- Is Transmural Healing an Achievable Goal in Inflammatory Bowel Disease?Pharmaceuticals (Basel, Switzerland) · 2025Review
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: The VERSIFY phase 3 trial in patients with Crohn's disease (CD) treated with vedolizumab was the first to include a substudy that used a standardized magnetic resonance enterography (MRE) protocol to assess features of transmural inflammation (bowel edema and wall thickness) and extramural disease activity (enlarged lymph nodes). Patients and Methods: Patients received intravenous vedolizumab (300 mg) at weeks 0 (baseline), 2, and 6, and then every 8 weeks for 26 or 52 weeks. Post hoc analyses included a subpopulation with a Magnetic Resonance Index of Activity score of ≥7 in at least one bowel segment at baseline and at least one postbaseline MRE assessment. Changes in transmural inflammation, including intramural bowel edema and wall thickness, were evaluated. Patient-level and segment-level analyses were performed. Results: MRE images were evaluated in 27 patients with 83 evaluable bowel segments at baseline and week 26, and 13 patients with 38 evaluable segments at baseline, week 26, and week 52. At baseline, all patients had bowel wall edema and wall thickness of >3 mm in at least one bowel segment. The proportion of patients with edema decreased at weeks 26 (17/27 [63.0%]) and 52 (4/13 [30.8%]) and the proportion with bowel wall thickness of >3 mm decreased at weeks 26 (25/27 [92.6%]) and 52 (10/13 [76.9%]). Conclusion: In patients with CD treated with vedolizumab for 26 and 52 weeks, the number of patients, and bowel segments, with MRE-detected transmural inflammation was reduced. These results highlight the impact of vedolizumab on components of transmural inflammation in CD and demonstrate that using MRE in CD multicenter clinical trials is feasible. Trial Registration: ClinicalTrials.gov NCT02425111, April 23, 2015, http://www.clinicaltrials.gov NCT02425111; EU Clinical Trials Register EudraCT 2014-003509-13, https://www.clinicaltrialsregister.eu.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.