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  ["project_title"]=>
  string(113) "Assessing the Impact of Disease Duration on the Likelihood of Healing in the Ileum and Colon in Crohn’s Disease"
  ["project_narrative_summary"]=>
  string(672) "Crohn's disease (CD) is a chronic condition affecting the digestive tract, particularly the ileum and colon. Healing these areas, known as endoscopic remission (ER), leads to better health outcomes. However, it is unclear if longer disease duration makes healing harder, especially in the ileum, which may be more challenging to treat.This study aims to determine if the length of time a person has had CD affects healing in the ileum versus the colon. We hypothesize that longer disease duration lowers the chances of healing, particularly in the ileum. This will help us understand how disease duration influences healing which can help inform treatment decision making."
  ["project_learn_source"]=>
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  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Neeraj"
    ["last_name"]=>
    string(6) "Narula"
    ["degree"]=>
    string(14) "MD, MPH, FRCPC"
    ["primary_affiliation"]=>
    string(24) "Hamilton Health Sciences"
    ["email"]=>
    string(26) "neeraj.narula@medportal.ca"
    ["state_or_province"]=>
    string(2) "ON"
    ["country"]=>
    string(6) "Canada"
  }
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      ["p_pers_f_name"]=>
      string(5) "Emily"
      ["p_pers_l_name"]=>
      string(4) "Wong"
      ["p_pers_degree"]=>
      string(2) "BS"
      ["p_pers_pr_affil"]=>
      string(24) "Hamilton Health Sciences"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
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  ["project_ext_grants"]=>
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    ["value"]=>
    string(2) "no"
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
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  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1477) "Background:

Crohn’s disease (CD) affects the ileum and colon, and endoscopic remission (ER) improves long-term outcomes. However, it is unclear if disease duration impacts healing differently in the ileum versus the colon. Longer disease duration may make healing, especially in the ileum, more difficult.



Objective:

To assess the impact of disease duration on ER in the ileum compared to the colon in moderate-to-severe CD patients.



Study Design:

Post-hoc analysis of pooled data from clinical trials of moderate-to-severe CD patients treated with active therapy. Endoscopic evaluations were performed at baseline, 12 weeks, and/or one year.



Participants:

Adults with moderate-to-severe CD who remained on the same therapy. Patients with incomplete endoscopic data or therapy switches were excluded.



Primary and Secondary Outcome Measures:



Primary outcome: ER (SES-CD < 3) in the ileum and colon at week 12 and one year.

Secondary outcome: Complete ER (SES-CD = 0), and MM-SES-CD < 22.5, stratified by disease duration (1 year).



Statistical Analysis:

Logistic regression will assess the effect of disease duration on ER. Univariate and multivariate analyses will evaluate covariates associated with ER. Analyses will follow an intention-to-treat approach, with group differences tested using Mann-Whitney U or Chi-squared tests.

"
  ["project_brief_bg"]=>
  string(1903) "Background

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can affect any part of the gastrointestinal tract but commonly involves the ileum and colon. The healing patterns and mechanisms of healing in these regions are not fully understood, and disease duration may influence the likelihood of achieving endoscopic remission (ER).



ER is assessed using the Simple Endoscopic Score for CD (SES-CD), which is a validated tool used to assess endoscopic disease severity. More recently, the modified multiplier of the SES-CD (MM-SES-CD) was developed and validated, which considers the individual parameters of the SES-CD and its associated prognostic value for achieving ER while on therapy (1, 2). ER is commonly defined in clinical trials for CD as SES-CD < 3, although more stringent definitions of ER, such as SES-CD of 0, are also used.  



Achieving ER in CD is important as it is associated with improved long-term outcomes, such as reduced relapse rates, lower hospitalization risks, and decreased need for surgery. However, the factors that influence the likelihood of achieving ER, particularly in different parts of the GI tract (i.e. ileum vs. colon), are not fully understood. Specifically, little is known about the impact that disease duration may have on ER in different parts of the ileum and colon. In the EXTEND clinical trial, it was demonstrated that 44% of adalimumab patients with disease duration of 5 years (3). However, it is unclear whether disease duration impacts likelihood of healing of the ileum and the colon similarly. Previously, it has been suggested that ileal ulcers are more difficult to heal than ulcers in other areas of the colon when treated with biologics and other therapies (4, 5). Stricture formation and other fibrotic changes in long-standing CD may contribute to difficulty in healing. 

"
  ["project_specific_aims"]=>
  string(264) "This study aims to evaluate whether disease duration has an impact on healing in the ileum compared to the colon in patients with CD. We hypothesize that there are significantly lower rates of ER in the ileum and colon among patients with shorter disease duration."
  ["project_study_design"]=>
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    ["value"]=>
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    ["label"]=>
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  }
  ["project_purposes"]=>
  array(2) {
    [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(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
    }
  }
  ["project_research_methods"]=>
  string(1011) "Study Design

This is a post-hoc analysis of clinical trials of patients with moderate-severely active CD who were treated throughout the entire study. 



Data from EXTEND (NCT00348283), U-EXCEL (NCT03345849), U-EXCEED (NCT03345836), U-ENDURE (NCT03345823), VISIBLE-2 (NCT02611817), VERSIFY (NCT02425111), SEAVUE (NCT03464136) (accessed via Vivli), UNITI-1 (NCT01369329), UNITI-2 (NCT01369342), and IM-UNITI (NCT01369355) will be pooled for this analysis. Participants will include adults with moderate to severely active CD who received active therapy and did not switch to other therapies during the study. 



Inclusion Criteria: Participants from the included trials who met eligibility criteria with moderate to severely active CD and were treated with the same therapy throughout the study. 



Exclusion Criteria: Participants with incomplete baseline endoscopic data and/or those who were switched to a different therapy at any point during the study. 

"
  ["project_main_outcome_measure"]=>
  string(628) "The primary outcome of this study is ER, defined as SES-CD < 3. Secondary outcomes of this study include alterative definitions of ER such as SES-CD of 0 and MM-SES-CD < 22.5. Stratified analyses will be performed to assess outcomes in the ileum and colon separately and whether disease duration impacts the likelihood of healing separately. In addition, outcomes will be assessed among participants based on baseline MM-SES-CD score (e.g.  31), using cut-offs of disease severity that were established previously. Outcomes will be assessed at one-year and at week 12 among trials with endoscopic data at these timepoints."
  ["project_main_predictor_indep"]=>
  string(284) "The main predictor variable of this study is disease duration, which is the time from diagnosis to start of study entry. Disease duration will be classified dichotomously using various cut-offs depending on the distribution of disease duration of the study population (e.g.  1 year). "
  ["project_other_variables_interest"]=>
  string(357) "Age (continuous), gender (male/female), smoking status (current/former/never), disease location (ileal/ileocolonic/colonic), concomitant steroid use (yes/no), prior biologic failure (yes/no), prior CD-related surgery (yes/no), Crohn’s disease activity index (continuous), fecal calprotectin levels (continuous), and C-reactive protein levels (continuous)."
  ["project_stat_analysis_plan"]=>
  string(1308) "Participant-level data of patients who received active therapy from multiple clinical trials will be pooled and analyzed. All analyses will be intention-to-treat (i.e. participants with missing outcome data will be assumed not to have achieved the outcome).



The proportion of participants achieving the outcomes in each group will be compared. Outcomes will be assessed at one-year and at week 12 among trials with endoscopic data available at this timepoint. Logistic regression may be used to assess disease duration on the outcome of interest. Univariate analyses will be conducted to identify associations between covariates and the outcome of interest, and any variables with a p-value < 0.05 will be included in the multivariate model, if more than one predictor is found to be significant on univariate analysis.



Continuous variables will be reported as means with standard deviations (SD) or as medians with interquartile ranges (IQR). Binary variables will be expressed as proportions or percentages. Descriptive statistics will summarize baseline demographics, disease features, and outcome measures for the included patients. Group differences will be assessed using the Mann-Whitney U test or Chi-squared test. Data analysis will be performed using Stata.

"
  ["project_software_used"]=>
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    [0]=>
    array(2) {
      ["value"]=>
      string(5) "stata"
      ["label"]=>
      string(5) "STATA"
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  ["project_timeline"]=>
  string(149) "Start date - December 2024

Completion date - March 2024

Manuscript draft - April 2024

Results reported back to YODA - April 2024"
  ["project_dissemination_plan"]=>
  string(481) "Results of this study will be shared through presentations and publications in peer-reviewed journals, such as Journal of Crohn’s and Colitis and the Journal of American College of Gastroenterology. Results arising from this study can be used by clinicians to better understand differential rates of healing across various ileocolonic segments. This understanding can guide treatment decision-making and better inform patients on their likelihood of achieving ER.



"
  ["project_bibliography"]=>
  string(1353) "
 

Narula N, Pray C, Wong ECL, Colombel JF, Marshall JK, Daperno M, et al. Categorising Endoscopic Severity of Crohn’s Disease Using the Modified Multiplier SES-CD [MM-SES-CD]. Journal of Crohn’s & colitis. 2022;16(7):1011-9.
Narula N, Wong ECL, Colombel JF, Sandborn WJ, Ferrante M, Marshall JK, et al. Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn’s Disease. Journal of Crohn’s & colitis. 2022;16(4):616-24.
Rutgeerts P, Van Assche G, Sandborn WJ, Wolf DC, Geboes K, Colombel JF, et al. Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease: data from the EXTEND trial. Gastroenterology. 2012;142(5):1102-11. e2.
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn’s Disease. The American journal of gastroenterology. 2022;117(7):1106-17.
Narula N, Wong ECL, Aruljothy A, Dulai PS, Colombel JF, Marshall JK, et al. Ileal and Rectal Ulcer Size Affects the Ability to Achieve Endoscopic Remission: A Post hoc Analysis of the SONIC Trial. The American journal of gastroenterology. 2020;115(8):1236-45.

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    ["caption"]=>
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    ["name"]=>
    string(47) "yoda-project-due-diligence-assessment-2024-0888"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(15795)
    ["date"]=>
    string(19) "2025-01-13 15:26:04"
    ["modified"]=>
    string(19) "2025-01-13 15:26:04"
    ["menu_order"]=>
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    ["mime_type"]=>
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    ["type"]=>
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    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_title_link"]=>
  array(21) {
    ["ID"]=>
    int(16371)
    ["id"]=>
    int(16371)
    ["title"]=>
    string(42) "YODA Project Protocol 2024-0888 - 24-11-18"
    ["filename"]=>
    string(44) "YODA-Project-Protocol-2024-0888-24-11-18.pdf"
    ["filesize"]=>
    int(130133)
    ["url"]=>
    string(93) "https://yoda.yale.edu/wp-content/uploads/2024/10/YODA-Project-Protocol-2024-0888-24-11-18.pdf"
    ["link"]=>
    string(86) "https://yoda.yale.edu/data-request/2024-0888/yoda-project-protocol-2024-0888-24-11-18/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(40) "yoda-project-protocol-2024-0888-24-11-18"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(15795)
    ["date"]=>
    string(19) "2025-01-13 15:25:47"
    ["modified"]=>
    string(19) "2025-01-13 15:25:47"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
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    ["subtype"]=>
    string(3) "pdf"
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  }
  ["project_review_link"]=>
  array(21) {
    ["ID"]=>
    int(16373)
    ["id"]=>
    int(16373)
    ["title"]=>
    string(36) "YODA Project Review - 2024-0888_SITE"
    ["filename"]=>
    string(38) "YODA-Project-Review-2024-0888_SITE.pdf"
    ["filesize"]=>
    int(1315606)
    ["url"]=>
    string(87) "https://yoda.yale.edu/wp-content/uploads/2024/10/YODA-Project-Review-2024-0888_SITE.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2024-0888/yoda-project-review-2024-0888_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
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    ["caption"]=>
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    ["name"]=>
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    ["uploaded_to"]=>
    int(15795)
    ["date"]=>
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    ["modified"]=>
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  }
  ["project_highlight_button"]=>
  array(3) {
    ["title"]=>
    string(22) "Publication Available!"
    ["url"]=>
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    ["target"]=>
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  }
  ["request_data_partner"]=>
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  ["human_research_protection_training"]=>
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  ["request_overridden_res"]=>
  string(1) "3"
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(1) {
  [0]=>
  string(6) "Canada"
}


pi affil
array(1) {
  [0]=>
  string(5) "Other"
}


products
array(1) {
  [0]=>
  string(7) "stelara"
}


num of trials
array(1) {
  [0]=>
  string(1) "4"
}


res
array(1) {
  [0]=>
  string(1) "3"
}