Evidence map›Paper›PMID 33279779›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2022

Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis.

Christopher Ma, Jenny Jeyarajah, Leonardo Guizzetti, Claire E Parker, Siddharth Singh, Parambir S Dulai, Geert R D'Haens, William J Sandborn, Brian G Feagan, Vipul Jairath

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01903252 (A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01903252 phase3completednot on this map

A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis

TypeinterventionalSponsorTillotts Pharma AGRan2013 to 2016Enrolled817ConditionsAcute Ulcerative ColitisArmsTP05, Asacol 400 mg
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Engineered Probiotics Mitigate Gut Barrier Dysfunction Induced by Nanoplastics.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  3. Article
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 3 countries.

Christopher MaDivision of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Alimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
Jenny JeyarajahAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
Leonardo GuizzettiAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
Claire E ParkerAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, University of California San Diego, La Jolla, California.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California.
Geert R D'HaensAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, Netherlands.
William J SandbornAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California.
Brian G FeaganAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Division of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Vipul JairathAlimentiv (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Division of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada. Electronic address: vjairath@uwo.ca.
Robarts Clinical Trials · CAUniversity of California San Diego · USWestern University · CAAmsterdam UMC Location University of Amsterdam · NLUniversity of Calgary · CA

Funding

San Diego Digestive Diseases Research CenterP30DK120515 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2019 to 2026
$10.8M
Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
Predicting Short- and Long-term Risk of Serious Infections in Older Patients with Inflammatory Bowel DiseasesR03DK129631 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2021 to 2022
$203k
NIDDK NIH HHS K23 DK117058NIDDK NIH HHS P30 DK120515NIDDK NIH HHS R03 DK129631
6 · The paper itself

Abstract

BACKGROUND &

aimsEndoscopic improvement is an important treatment target for mild-to-moderate ulcerative colitis (UC). However, early endoscopic evaluation is not always feasible. We aimed to develop a clinical decision support tool to discriminate patients who have achieved endoscopic improvement from those with more severe inflammation following mesalamine induction therapy.

methodsWe performed a post-hoc analysis of data from a phase 3 non-inferiority trial of 726 adults with mild-to-moderate UC treated with mesalamine. Multivariable logistic regression modeling determined associations between candidate variables and endoscopic improvement (Mayo endoscopic subscore=0-1 according to blinded central reading) at Week 8. Internal model validation was performed using bootstrap resampling. A clinical decision support tool was developed to stratify patients into low, intermediate, and high probability groups for endoscopic improvement.

resultsVariables associated with endoscopic improvement at Week 8 included 50% reduction in fecal calprotectin from baseline (odds ratio [OR] 2.64, 95% CI:, 1.81, 3.85), reduction in rectal bleeding (OR 1.79 per point reduction, 95% CI: 1.35, 2.39), and improvement in physician global assessment (OR 2.32 per point improvement, 95% CI: 1.88, 2.85). The baseline Geboes score (OR 0.74 per grade, 95% CI: 0.65, 0.85) and prolonged disease duration (OR 0.95 per year, 95% CI: 0.92, 0.98) were negatively associated with endoscopic improvement. This model strongly discriminated endoscopic improvement in the development dataset (area under the curve [AUC] 0.84, 95% CI: 0.81, 0.87) and during validation (AUC 0.83).

conclusionsWe developed and validated a clinical decision support tool that has good discriminative performance for induction of endoscopic improvement in patients with mild-to-moderate UC treated with mesalamine. ClinicalTrials.gov Registration: NCT01903252.

Indexed as

Colitis, UlcerativeMesalamineAdultEndoscopyFecesHumansLeukocyte L1 Antigen ComplexRemission InductionLeukocyte L1 Antigen ComplexMesalamineEndoscopic ImprovementEndoscopyMesalamineMucosal HealingUlcerative Colitis

Identifiers

PMID33279779
PMCPMC8588993
OpenAlexW3106560430

What OpenQuestion holds

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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.