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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(306) "NCT01369329 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)"
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      string(232) "NCT00207662 - ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease"
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  ["project_title"]=>
  string(113) "Predictability of biomarkers and disease activity indices for efficacy of advanced therapies in Crohn’s disease"
  ["project_narrative_summary"]=>
  string(675) "Crohn’s Disease (CD) is a common chronic inflammatory disease impacting multiple layers of the colon. Assessment of disease activity in CD typically includes evaluations of patient-reported outcomes and biomarkers of inflammation. Typically, baseline measurements are compared at different time points to examine if symptoms are improving and outcomes are classified as a treatment response or disease remission. Currently used criteria for outcome measures may inadequately capture improvements in less severe individuals and do not include objective measurements. Additionally, it is unknown what the minimal clinically important differences (MCID) are for each measure. "
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(5) "Shane"
    ["last_name"]=>
    string(7) "Goodwin"
    ["degree"]=>
    string(3) "PhD"
    ["primary_affiliation"]=>
    string(18) "Western University"
    ["email"]=>
    string(24) "shane.goodwin@lhsc.on.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
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      ["p_pers_f_name"]=>
      string(5) "Dhruv"
      ["p_pers_l_name"]=>
      string(5) "Ahuja"
      ["p_pers_degree"]=>
      string(4) "MBBS"
      ["p_pers_pr_affil"]=>
      string(40) "Indira Gandhi Hospital, New Delhi, India"
      ["p_pers_scop_id"]=>
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      ["requires_data_access"]=>
      string(3) "yes"
    }
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      ["p_pers_f_name"]=>
      string(7) "Sudheer"
      ["p_pers_l_name"]=>
      string(5) "Kumar"
      ["p_pers_degree"]=>
      string(12) "MBBS, MD, DM"
      ["p_pers_pr_affil"]=>
      string(54) "University of Western Ontario, London, Ontario, Canada"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
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      ["p_pers_f_name"]=>
      string(5) "Vipul"
      ["p_pers_l_name"]=>
      string(7) "Jairath"
      ["p_pers_degree"]=>
      string(5) "DPhil"
      ["p_pers_pr_affil"]=>
      string(54) "University of Western Ontario, London, Ontario, Canada"
      ["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(1633) "Background: Crohn’s Disease (CD) is a common chronic illness impacting millions worldwide. Assessment of disease activity includes use of patient-reported outcomes and biomarkers of inflammation. It is not clear if currently used criteria are optimal with concerns in the ability of current improvement criteria being inadequate for less sever patients. Additionally, currently used measures do not include objective indicators of inflammation such as C-reactive protein (CRP). Finally, it is unclear the minimal clinically important differences (MCID) of each measure. 

Objective: Investigate optimal cut-off scores and minimal clinically significant differences of disease indices (CDAI, PRO-2, CDEIS, and SES-CD) for patients with moderate to severe CD. Secondary objectives are to examine the impact of disease activity and location on disease index performance and the correlations between clinical symptoms and endoscopic activity at baseline. 

Study Design: This study is an individual participant data (IPD) meta-analysis to assess optimal cut-off scores and MCID of disease indices. Pivotal phase 3 CD trials were identified. 

Participants: CD patients

Primary and Secondary Outcome Measures: Clinical response and remission, endoscopic response and remission captured using CDIA, PRO2, SES-CD, and CDEIS.

Statistical Analysis: Optimal cut-off scores will be explored using ROC curve meta-analyses, obtaining pooled estimates of specificity, sensitivity, and associated 95% confidence intervals. MCID will follow distributional and anchor approaches to estimate impact in outcome scores."
  ["project_brief_bg"]=>
  string(1595) "Inflammatory bowel disease (IBD) is a common condition that causes chronic inflammation to the gastrointestinal (GI) tract, impacting 6.8 million people around the world (Global Burden of Disease Inflammatory Bowel Disease Collaborators, 2020). The two types of IBD include ulcerative colitis (UC) and Crohn’s disease (CD). In CD, inflammation occurs in any part of the GI tract, affecting multiple layers of the colon. Assessment of disease activity in CD typically includes evaluations of patient-reported outcomes, biomarkers of inflammation in the blood (C-reactive protein and fecalprotectin), along with clinical indicators such as histology and endoscopy results (Ma et al., 2018).



Examining improvements of CD is typically based on changes from baseline in one or more indices. Additionally, improvements can be described as clinical or endoscopic, based on choice of measures, and outcomes are typically defined as a response or remission. The different choices available to categorize an improvement results in complexity in determining the efficacy of a new drug or treatment strategy. 



Despite the common use of each index, there is debate on the optimal choice of a cut-off and whether more objective measures of inflammation, such as C-reactive protein (CRP) should be used (Peyrin-Biroulet et al. 2014). Additionally, there are questions surrounding the adequacy of each index to capture improvement in less severe patients. Finally, the minimal clinically important differences (MCID) of each measure are not well described (Sandborn et al. 2002)."
  ["project_specific_aims"]=>
  string(521) "The primary objective of this study is to explore optimal cut-off scores and minimal clinically significant differences of disease indices (CDAI, PRO-2, CDEIS, and SES-CD) for patients with moderate to severe Crohn’s disease .



The secondary objectives of this study is 

1. To examine the impact of disease activity and disease location on disease index performance.

2. To examine the cross sectional correlation between clinical symptoms and endoscopic disease activity at baseline 

"
  ["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(909) "This is an individual participant data (IPD) meta-analysis to assess explore optimal cut-off scores and minimally clinically signifiant differences of disease indices (CDAI, PRO-2, CDEIS, and SES-CD) for patients with moderate to severe Crohn’s disease (CD). Recently published pivotal phase 3 CD trials were identified. IPD (baseline demographics and disease characteristics) will be obtained for induction and maintenance trials. 



There are no exclusion criteria and all individuals will be included in the analyses. 



The data from the YODA platform will be combined with studies from the Vivli platform. The external studies included in the analysis are as follows:

NCT01224171

NCT00783692

NCT03345849

NCT03345836

NCT00077779

NCT00055497

NCT00445939

NCT00445432

NCT00348283

NCT02611817

NCT02038920"
  ["project_main_outcome_measure"]=>
  string(1194) "The primary outcome of this study is to find new optimal cut-offs for  several disease indices: Crohn’s Disease Activity Index (CDAI), 2-item patient-reported outcome (PRO2), Stool frequency (SF), Abdominal pain (AP), Simple Endoscopic Score for Crohn’s Disease (SES-CD), and Crohn’s Disease Endoscopic Index of Severity (CDEIS). These indices are used to define four outcomes: clinical response, clinical remission, endoscopic response, and endoscopic remission. In this project we will be examining optimal cut-offs and compare to those currently used in the literature. The current definitions for each clinical outcome are:



1. Clinical response: a decrease from baseline in the total CDAI of ≥ 70 points / ≥ 100 points); or a decrease from baseline in the PRO2 of 5 points / 8 points.

2. Clinical remission: an endpoint CDAI score ≤ 150 points or an endpoint PRO2 score ≤ 8 points or a stool frequency at endpoint ≤ 1.5 and abdominal pain at endpoint ≤1.0, with neither worse than baseline score.

3. Endoscopic response: reduction of ≥25% /  ≥50% from baseline in the SES-CD/CDEIS

4. Endoscopic remission:  SES-CD/CDEIS ≤4 / ≤2 "
  ["project_main_predictor_indep"]=>
  string(1063) "As this study is a validation to find new optimal cut-off scores the main predictors are changes in Crohn’s Disease Activity Index (CDAI), 2-item patient-reported outcome (PRO2), Stool frequency (SF), Abdominal pain (AP), Simple Endoscopic Score for Crohn’s Disease (SES-CD), and Crohn’s Disease Endoscopic Index of Severity (CDEIS). In this project we will be examining optimal cut-offs and compare to those currently used in the literature. The current definitions for each clinical outcome are:



1. Clinical response: a decrease from baseline in the total CDAI of ≥ 70 points / ≥ 100 points); or a decrease from baseline in the PRO2 of 5 points / 8 points.

2. Clinical remission: an endpoint CDAI score ≤ 150 points or an endpoint PRO2 score ≤ 8 points or a stool frequency at endpoint ≤ 1.5 and abdominal pain at endpoint ≤1.0, with neither worse than baseline score.

3. Endoscopic response: reduction of ≥25% /  ≥50% from baseline in the SES-CD/CDEIS

4. Endoscopic remission: SES-CD/CDEIS ≤4 / ≤2 "
  ["project_other_variables_interest"]=>
  string(543) "Key other predictors that will be included to meet our secondary objectives are albumin levels, c-reactive protein (CRP) levels, fecal calprotectin (FCP) levels and disease location (ileal, ileoclonic, colonic).



Other covariates for adjustment include disease location (ileal, colonic, ileocolonic), disease duration (years), and concomitant corticosteroid use (Any, Greater than 20mg per day, None), age (years), race (white, black, asian, other), sex (male, female), and concomitant medication use (presence, absence).

"
  ["project_stat_analysis_plan"]=>
  string(3317) "Appropriate descriptive statistics will be presented for demographic and baseline characteristics for both the entire study sample and according to each study treatment arm (active or placebo). 



To determine optimal cut-off scores we will first explore use of receiver operating characteristic (ROC) curve analyses, Youden’s index in each of the separate clinical trials. Following this, we will use bivariate meta-analyses to obtain pooled estimates of specificity, sensitivity, and their associated 95% confidence intervals, and use this to produce 95% confidence ellipse within the ROC space (Reitsma et al. 2005; Walter 2002). Here, each data point represents a specific trial based upon the measurement characteristics from each study and we are able to take into account that each study has a unique design and characteristics. Bivariate meta-analyses allows for correlations between pairs of sensitivity and specificity within a study using a two-staged random effects approach. First, correlations are transformed using Fisher Z-transformations and then correlations will be pooled using the generic inverse variance pooling method. A random-effects model with the restricted maximum likelihood estimator is then conducted to obtain pooled sensitivity and specificity are obtained with 95% confidence ellipses to take into account the heterogeneity across studies.  Study heterogeneity will be explored (Higgins et al. 2003) and reported on. 



Examination of the minimal clinically important difference (MCID) will follow two approaches: a distribution-based approach and an anchor approach (Rai et al. 2015). In the distribution approach, the MCID is estimated based on a 0.5 standard deviation of the mean change score (Mouelhi et al. 2020). Again, the same two-stage bivariate meta-analyses to obtain pooled estimates for the distribution of MCID will be conducted to adjust for any study-specific effects. Under the anchor approach, the average change in those who respond to intervention vs those who do not is used to estimate the MCID (Mouelhi et al. 2020) and will be conducted using meta-regression with study cluster as as a random effect and adjusted for clinical characteristics. Inclusion of clusters adjust for the correlation of individuals within studies. 



For the secondary outcomes including CRP and FCP levels, log-transformed endpoint CRP and FCP will be included in meta-regression models with other patient characteristics (age, sex, disease duration). Accuracy of diagnostic cut-offs based on levels of CRP and FCP will be examined for both active and placebo treatment arms via statistical interactions. All analyses will be conducted in SAS and R.



To maintain the structure and independence of the studies being requested, each study will be kept as a separate file. When combining the results of the studies into a single dataset for pooled analysis, we will create a variable that uniquely identifies each study (study ID).



Analyses will be run as complete information (excluding missingness), however we will explore the extent and type of missingness to determine whether it would be appropriate to impute any missingness. If any imputations are conducted, they would occur within a study before pooling."
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
    }
  }
  ["project_timeline"]=>
  string(193) "Project start date: June 1, 2025

Analysis completion date: December 1, 2025

Abstract and manuscript drafted: January 1, 2026

Submission to journal: February 1, 2026

"
  ["project_dissemination_plan"]=>
  string(761) "We anticipate that the analysis will result in a manuscript in a specialty gastrointestinal or Inflammatory Bowel Disease journal such as:  Alimentary Pharmacology & Therapeutics, Gut, Gastroenterology, Clinical Gastroenterology and Hepatology, or Journal of Cohn’s and Colitis.  We also anticipate the sharing of the resulting information through presentation at relevant international conferences (e.g., Digestive Disease Week (DDW), and the European Crohn’s and Colitis Organization Congress (ECCO)). 



The results from this study will have several stakeholders. The immediate target audience are clinicians treating patients with IBD and those involved in designing clinical trials (primarily researchers, investigators, and industry)."
  ["project_bibliography"]=>
  string(2092) "
Global Burden of Disease 2017 Inflammatory Bowel Disease Collaborators. (2020). The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet Gastroenterology & Hepatology, 5(1), 17-30. https://doi.org/10.1016/S2468-1253(19)30333-4 
Higgins JPT, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ 2003;327:557–60
Ma C, Hussein IM, Al-Abbar YJ, et al. (2018). Heterogeneity in definitions of efficacy and safety endpoints for clinical trials of Crohn’s disease: a systematic review. Clin Gastroenterol Hepatol, 16:1407-1419. https://doi.org/10.1016/j.cgh.2020.10.039
Mouelhi Y, Jouve E, Castelli C, Gentile S. How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. Health and Quality of Life Outcomes. 2020;18: 136. 
Peyrin-Biroulet L, Reinisch W, Colombel J, et al Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn’s disease in the SONIC trial Gut 2014;63:88-95.
Rai SK, Yazdany J, Fortin PR, Aviña-Zubieta JA. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Research & Therapy 2015; 17:143.
Reitsma JB, Glas AS, Rutjes AW, et al. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. J Clin Epidemiol 2005;58:982–90
Sandborn WJ, Feagan BG, Hanaeur SB, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterol. 2002; 122:512-530.
Walter SD. Properties of the summary receiver operating characteristic (SROC) curve for diagnostic test data. Stat Med 2002; 21:1237–56.
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