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      string(251) "NCT03464136 - A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease"
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      string(238) "NCT01369355 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease"
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      string(258) "NCT02407236 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis"
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  ["project_title"]=>
  string(116) "The Association Between Disease Duration and Both Endoscopic and Histological Findings in Inflammatory Bowel Disease"
  ["project_narrative_summary"]=>
  string(795) "Inflammatory Bowel Disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic inflammatory condition with rising global prevalence. Our research asks: does longer disease duration make gut healing more difficult? Prior work shows longer duration worsens clinical outcomes in CD but not UC, yet its impact on endoscopic and histological outcomes—key predictors of long-term prognosis —remains unknown. We will perform a pooled analysis of 20 clinical trials, encompassing thousands of patients, to assess the effect of disease duration while adjusting for confounders (age, therapy, baseline severity). Findings will clarify whether early and complete control of inflammation improves long-term healing, guiding treatment strategies to enhance patient outcomes."
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Sun-Ho"
    ["last_name"]=>
    string(3) "Lee"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(20) "Mount Sinai Hospital"
    ["email"]=>
    string(25) "Sun-Ho.Lee@sinaihealth.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
  ["project_key_personnel"]=>
  array(1) {
    [0]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(6) "Rirong"
      ["p_pers_l_name"]=>
      string(4) "Chen"
      ["p_pers_degree"]=>
      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(20) "Mount Sinai Hospital"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
  }
  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(2) "no"
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1683) "Background

Inflammatory Bowel Disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing inflammatory condition with rising global prevalence. While longer disease duration is linked to poor clinical outcomes in CD, its impact on endoscopic and histological healing—key predictors of long-term prognosis—remains unclear.



Objective

To investigate the association between disease duration and endoscopic as well as histological outcomes in IBD.



Study Design

Participant-level pooled analysis of 20 randomized clinical trials (e.g., UNIFI, SELECTION, VARSITY, LUCENT, OCTAVE, UNITI, U-EXCEL, U-EXCEED, U-ENDURE, ADVANCE, MOTIVATE).



Participants

Thousands of patients with CD or UC enrolled in clinical trials with available disease duration, treatment, and outcome data. Disease duration is defined as time from diagnosis to trial enrollment.



Primary and Secondary Outcome Measure(s)

The primary outcomes are endoscopic and histological healing endpoints at the end of induction and maintenance therapy. Secondary outcome is combined histo-endoscopic improvement (both endoscopic and histological improvement achieved).



Statistical Analysis

Restricted cubic splines will examine linear/nonlinear associations. Logistic regression models (univariate and multivariable) will test associations, adjusting for age, sex, baseline severity, treatment, and concomitant therapy. Random-effects meta-analysis will yield pooled estimates, with heterogeneity assessed by Q test and I². Subgroup analyses will explore effect modifiers."
  ["project_brief_bg"]=>
  string(2626) "Inflammatory Bowel Disease (IBD) is a long-term illness that causes inflammation (swelling and damage) in the digestive system. The two main types of IBD are Crohn’s disease (CD) and ulcerative colitis (UC). CD most commonly affects the end of the small intestine and the beginning of the large intestine. UC causes inflammation and sores, called ulcers, in part of the digestive tract and affects the innermost lining of the large intestine, called the colon, and rectum. Symptoms usually develop over time, rather than coming on suddenly. People with IBD often experience ongoing symptoms such as stomach pain, diarrhea, and fatigue, with periods of flare-ups and relief. The number of people living with IBD is increasing, especially in North America, Europe, and many developing countries. As more people are diagnosed, it becomes important to understand how the disease changes over time and how best to treat it.



Our research will explore whether having IBD for a longer time makes it harder for the gut to fully heal. Healing will be assessed using two tools: endoscopy (a camera used to view the inside of the gut) and histology (examining tissue samples under a microscope). These methods can detect signs of inflammation that may not be obvious through symptoms alone. In fact, current thinking suggests that healing seen on endoscopy or histology is more useful for predicting long-term health than symptoms alone.



Past research has shown that a longer disease duration may lead to worse outcomes in Crohn’s disease, but we still do not know if this also affects healing seen on endoscopy or histology in either CD or UC. Our study will help answer this question.



To do this, we will combine data from 20 previous clinical trials to create a large dataset with thousands of patients. This type of analysis, called a pooled analysis, allows us to look for patterns that smaller studies might miss. We will also take into account other important factors such as the patient’s age, type of treatment, and how severe their disease was when they started the study. This will help us better understand the true relationship between how long someone has had IBD and their chances of gut healing.



By doing this research, we aim to better understand how time with the disease affects the healing process. Our findings may help doctors make more informed treatment decisions and encourage earlier and more effective control of inflammation. Ultimately, this could lead to better long-term health and quality of life for people living with IBD.



"
  ["project_specific_aims"]=>
  string(1044) "This study aims at investigating the association between disease duration and endoscopic as well as histological outcomes in patients of inflammatory bowel disease. 



Aim 1: Assess the association between disease duration (continuous and categorical) and endoscopic outcomes (remission, improvement) at induction and maintenance across pooled clinical trial datasets.

Hypothesis 1: Longer disease duration is independently associated with reduced likelihood of achieving endoscopic healing.



Aim 2: Evaluate the association between disease duration and histological outcomes (remission, improvement) in IBD.

Hypothesis 2: Longer disease duration predicts poorer histological healing, independent of treatment allocation and baseline severity.



Aim 3: Examine the relationship between disease duration and combined histo-endoscopic outcomes to define its impact on deep healing.

Hypothesis 3: Patients with shorter disease duration are more likely to achieve deep remission.

"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(56) "participant_level_data_meta_analysis_from_yoda_and_other"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
  }
  ["project_research_methods"]=>
  string(1713) "Data Source

Primary data will be obtained from YODA-hosted Janssen trials with endoscopic/histologic endpoints and baseline disease duration, including UNIFI (UC) and UNITI/IM-UNITI (CD); OCTAVE (UC) if available.



Inclusion Criteria



Confirmed diagnosis of UC or CD per trial protocol.



Age ≥18 years at randomization.



Disease duration recorded at baseline (diagnosis → trial entry).



Baseline and post-baseline endoscopic score(s) (UC: MES; CD: SES-CD).



Histology available at baseline and follow-up where collected (UC: Geboes; CD: GHAS or trial-defined index).



Randomized to any trial arm (including placebo) with evaluable outcomes.



Exclusion Criteria



Missing key variables (disease duration, baseline, or post-baseline endoscopy/histology).



Non-evaluable anatomy (e.g., prior colectomy in UC; absent segment in CD).



Major protocol deviations invalidating efficacy outcomes.



Stoma/short bowel where endpoints cannot be scored.

If none apply → None beyond protocol-defined criteria.



Other Studies and Platforms

Additional trials with comparable endpoints will be requested via Vivli (e.g., SELECTION, VARSITY, LUCENT, U-EXCEL, U-EXCEED, U-ENDURE, ADVANCE, MOTIVATE).



Pooling and Analysis

Where permitted, IPD will be harmonized for a pooled analysis in a secure environment. If cross-platform pooling is restricted, identical analysis code will be run on each platform, generating study-level adjusted effect estimates to be combined using random-effects meta-analysis."
  ["project_main_outcome_measure"]=>
  string(1030) "The primary outcomes are endoscopic and histological healing endpoints at the end of induction and maintenance therapy.



Ulcerative Colitis:

Endoscopic remission: Mayo Endoscopic Subscore (MES) = 0

Endoscopic improvement: MES <= 1

Histological remission: Geboes < 2

Histological improvement: Geboes < 3.2

Crohn's Disease:

Endoscopic remission: Simple Endoscopic Score (SES)-CD =50% decrease in SES-CD from baseline

Histological remission: Global Histological Activity Score (GHAS) =50% decrease in GHAS from baseline



Secondary Outcome Measures

Combined histo-endoscopic improvement (both endoscopic and histological improvement achieved).

Subgroup analyses stratified by age (=40), sex, disease location, prior biologic exposure, and treatment class.

Exploratory analyses of duration as categorical (quartiles, Restricted cubic spline (RCS)-derived cutoffs, early vs established disease [=18 months]).



"
  ["project_main_predictor_indep"]=>
  string(1179) "The main independent variable is disease duration, defined as the length of time between the initial diagnosis of IBD and the date of trial enrollment/randomization, measured in months or years as reported in the trial dataset. Disease duration captures cumulative disease burden prior to trial entry and will be evaluated as both a continuous and categorical variable.



Continuous Definition

Disease duration will first be modeled as a continuous predictor (per year increase) to evaluate its direct association with endoscopic and histological outcomes.



Categorical Definitions

Quartiles (Q1--Q4): Participants stratified by quartile distribution of disease duration within each dataset to identify threshold effects.

Restricted cubic spline cut-offs: Data-driven thresholds derived from RCS analysis to explore non-linear associations.



Clinical threshold (=18 months): Based on the Paris consensus definition of early vs established Crohn's disease, reflecting international expert opinion [1]. While originally developed for CD, this threshold will be explored for UC for consistency and comparability.

"
  ["project_other_variables_interest"]=>
  string(1690) "Other Variables of Interest

In addition to disease duration, several clinical and demographic variables will be included to characterize the study sample and adjust for potential confounders in multivariable models. These variables will be harmonized across trials where possible.

Demographics

Age at baseline: continuous (years) and categorical (=40).

Sex: male vs female.

Body mass index (BMI): continuous (kg/m^2) and categorized per World Health Organization (WHO) definitions (normal, overweight, obese).



Disease Characteristics

Disease type: (CD) vs (UC).

Disease location/extent: classified according to Montreal classification (e.g., ileal, colonic, ileocolonic for CD; Extent (E1--E3) for UC) where available.



Baseline disease activity:

UC: partial Mayo score;

CD: Crohn's Disease Activity Index (CDAI);

Both: biochemical activity (fecal calprotectin, CRP).

Baseline endoscopic and histological scores (MES, SES-CD, Geboes, GHAS) as continuous and categorical variables.



Treatment Variables

Treatment allocation: active drug vs placebo.

Type of therapy: biologic class (anti-tumor necrosis factor, (TNF), anti-integrin, anti-interleukin inhibitors (IL)-12/23, Janus kinase inhibitor (JAK) inhibitor).

Concomitant corticosteroid or immunomodulator use: yes/no.

Prior exposure to biologics: biologic-naïve vs biologic-experienced.



Other Variables

Geographic region: trial-defined region (e.g., North America, Europe, Asia).

Smoking status (for CD): current, former, never (if available).



"
  ["project_stat_analysis_plan"]=>
  string(4148) "Overview

The primary objective is to evaluate whether disease duration independently predicts endoscopic and histological outcomes in IBD. Analyses will follow a pre-specified plan to ensure transparency and reproducibility, using harmonized definitions across trials. Analyses will be performed in R (version >=4.0), with two-sided < 0.05 considered statistically significant unless adjusted for multiple testing.



1. Descriptive Analyses

Baseline demographic and clinical characteristics will be summarized by quartiles of disease duration and by trial. Continuous variables will be expressed as median (interquartile range, IQR) or mean (standard deviation, SD) depending on distribution.

Categorical variables will be summarized as counts and percentages. 

Group comparisons: Mann--Whitney U test or Student's t-test for continuous variables; Chi-square or Fisher's exact test for categorical variables.



2. Primary Analyses (Association of Disease Duration with Outcomes)

Restricted Cubic Spline (RCS) Models: To explore potential non-linear relationships between disease duration and outcomes. Knots will be placed at the 5th, 35th, 65th, and 95th percentiles.

Logistic Regression: Univariate models will estimate crude odds ratios (ORs) for each outcome (endoscopic/histological remission and improvement, combined histo-endoscopic endpoints). Multivariable models will adjust for confounders: age, sex, baseline disease activity (clinical, endoscopic, histologic, biomarkers), prior biologic exposure, treatment allocation/class, and concomitant corticosteroid or immunomodulator use.

Disease duration will be tested as both a continuous (per year increase) and categorical predictor (quartiles, =18 months, RCS-defined cutoffs).



3. Secondary and Exploratory Analyses

Subgroup Analyses: Stratified by age (=40), sex, disease type (UC vs CD), disease location, prior biologic exposure, and therapy class.

Interaction Terms: Tested in regression models to explore whether the effect of disease duration differs by subgroup.

Sensitivity Analyses: Excluding patients with missing or extreme values, or restricting to biologicnaïve cohorts.



4. Missing Data

Patients missing the key predictor (disease duration) will be excluded.

Other missing covariates will be addressed using multiple imputation by chained equations (MICE), assuming missing at random. Ten imputations will be generated, and results combined using Rubin's rules.



5. Meta-Analysis Across Trials

If Individual Participant Data (IPD) pooling across platforms (e.g., YODA, Vivli) is not feasible, identical analysis code will be executed within each platform.

Adjusted odds ratios and 95% confidence intervals (CIs) will be extracted for each outcome and combined using a DerSimonian--Laird random-effects meta-analysis. Heterogeneity will be assessed with Cochran's Q test and quantified using the I^2 statistic.



6. Time-to-Event Analyses (Exploratory)

For trials with longitudinal follow-up to relapse or colectomy/resection, Kaplan--Meier curves will be generated, and differences compared using the log-rank test. Cox proportional hazards models will assess the effect of disease duration on time-to-event

outcomes, adjusting for the same covariates as logistic regression. Proportional hazards assumptions will be tested using Schoenfeld residuals.



7. Multiple Testing and Robustness

The primary analysis focuses on four prespecified outcomes (endoscopic remission, endoscopic improvement, histological remission, histological improvement). Bonferroni correction will be applied where appropriate. Bootstrap resampling (1,000 iterations) will be used to assess the robustness of effect estimates.



8. Reporting

Results will be presented as adjusted ORs (95% CIs) for categorical outcomes, adjusted hazard ratios (95% CIs) for time-to-event analyses, and spline plots for continuous disease duration effects.

"
  ["project_software_used"]=>
  array(2) {
    [0]=>
    array(2) {
      ["value"]=>
      string(1) "r"
      ["label"]=>
      string(1) "R"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
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  ["project_timeline"]=>
  string(976) "Project Timeline



Project Start (Data Access Granted): February 23, 2026



Data Harmonization and Cleaning: February – April 2026



Primary Analyses (disease duration vs. outcomes): May – August 2026



Secondary/Subgroup Analyses and Sensitivity Analyses: September – November 2026



Drafting of Manuscript: December 2026 – January 2027



First Manuscript Submission to Journal: February 2027



Abstract Preparation and Conference Submission (DDW/ECCO): February – March 2027



Final Analyses/Responses to Peer Review (if needed): March – May 2027



Report of Results to YODA Project: June 2027



This timeline aligns with the 12-month data access period, allowing for comprehensive analyses, manuscript preparation, and dissemination. An extension will be requested if additional analyses or peer-review revisions require more time."
  ["project_dissemination_plan"]=>
  string(1414) "Dissemination Plan



The findings of this study will be disseminated broadly to maximize scientific and clinical impact. The primary product will be a manuscript reporting the association between disease duration and endoscopic/histological outcomes in IBD, targeted to high-impact, peer-reviewed journals such as Gastroenterology, Gut, or Clinical Gastroenterology and Hepatology. If appropriate, a secondary manuscript may focus on subgroup analyses (e.g., biologic-naïve vs experienced, early vs established disease).



Results will also be presented at leading international meetings, including Digestive Disease Week (DDW), the European Crohn’s and Colitis Organization (ECCO) Congress, and other gastroenterology conferences. Summaries tailored for clinician education will be shared through society workshops, hospital grand rounds, and professional networks.



The target audience includes gastroenterologists, clinical trialists, translational researchers, guideline committees, and policy makers. By clarifying whether disease duration affects the likelihood of deep healing, this work has the potential to inform treat-to-target strategies, optimize trial design, and guide earlier intervention in IBD.



All publications and presentations will acknowledge the YODA Project and data-contributing sponsors in accordance with data-sharing agreements."
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References

[1] Dolinger M et al . Crohn’s disease. Lancet. 2024;403:1177-1191.

[2] Le Berre C, et al. Ulcerative colitis. Lancet. 2023;402:571-584.

[3] Hracs L, Windsor JW, Gorospe J, et al. Global evolution of IBD across epidemiologic stages. Nature. 2025;642:458-466.

[4] Ben-Horin S, Novack L, Mao R, et al. Efficacy of biologics in short- vs long-duration IBD. Gastroenterology. 2022;162:482-494.

[5] Turner D, Ricciuto A, Lewis A, et al. STRIDE-II therapeutic targets in IBD. Gastroenterology. 2021;160:1570-1583.

[6] Neurath MF, Vieth M. Levels of healing in IBD. Gut. 2023;72:2164-2183.

[7] Ungaro RC, Yzet C, Bossuyt P, et al. Deep remission prevents progression in early CD. Gastroenterology 2020;159:139-147.
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