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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(130) "Disease characteristics influencing the efficacy and safety of advanced therapies in moderate to severely active Crohn’s disease"
  ["project_narrative_summary"]=>
  string(690) "Crohn’s Disease (CD) is a common chronic inflammatory disease of the colon. Treatment trajectories are complex and patients may switch treatment strategies several times through their lives. Despite the complex history of patients, much of this information is disregarded during investigating treatment efficacy. Adding to the complexity in treatment decisions, patients present with unique combinations of age, sex, and race. As such, it is unknown if disease characteristics and such as disease location, history of surgery, or prior treatment failure may impact treatment efficacy, and whether these disease characteristics have different impacts based on a patients age, sex, or race."
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  array(7) {
    ["first_name"]=>
    string(5) "Shane"
    ["last_name"]=>
    string(7) "Goodwin"
    ["degree"]=>
    string(15) "Doctoral Degree"
    ["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(7) "Sudheer"
      ["p_pers_l_name"]=>
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      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(18) "Western University"
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      string(5) "Ahuja"
      ["p_pers_degree"]=>
      string(4) "MBBS"
      ["p_pers_pr_affil"]=>
      string(40) "Indira Gandhi Hospital, New Delhi, India"
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      ["p_pers_l_name"]=>
      string(7) "Jairath"
      ["p_pers_degree"]=>
      string(5) "DPhil"
      ["p_pers_pr_affil"]=>
      string(37) "Western University, London ON, 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(1627) "Background: Crohn’s Disease (CD) is a common chronic illness of the colon. Despite complex histories and unique patient characteristics of individuals entering clinical trials, much of this information is disregarded. As such, it is unknown the extent prior patient history and disease-characteristics have on treatment efficacy and how these relationships are impacted by different age, sex, and race intersections. 

Objective: Investigate whether treatment effect and safety differs in moderate to severely active Crohn’s disease patients based on disease-related characteristics and how this relationship is modified by the intersection of age, sex, and race. 

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 and endoscopic response and remission, captured using CDIA, PRO2, SES-CD, and CDEIS, and individual symptoms of stool frequency and rectal bleeding, changes in CRP and fecal calprotectin, and risk of infections and adverse events.

Statistical Analysis: Modified Poisson regression will assess treatment effects by patient prior history (prior surgical resection, treatment failure, treatment intolerance, and drug concomitant use) and disease characteristics (disease location). Intersectional effects of age, sex, and race will be examined using multilevel models. Study-specific estimates and 95% two-sided confidence intervals will be obtained for all outcomes."
  ["project_brief_bg"]=>
  string(2550) "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). In Crohn’s disease (CD), inflammation affects multiple layers of the colon. Assessment of disease activity 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).



The treatment trajectory for patients with CD is complex and response can be influenced by several disease-related including disease location and prior history of treatment (prior bowel surgeries, prior treatment failure, and prior treatment intolerance). Understanding how these prior history factors impact treatment response can help in tailoring appropriate treatment strategies. However, knowledge of the impact of different characteristics of a patients history on treatment is limited. For example, despite the evidence that a significant proportion of patients with CD will require bowel surgery during their life and are at increased risk of future bowel surgeries (De Cruz et al. 2015), it is unknown if patients may respond different to new therapies compared to those who have not undergone bowel surgery. Similarly, despite a third of patients not responding to initial treatment (Gisbert et al. 2015), it is unknown if these patients will respond to new treatments in the same manner as those not carrying a complex history into a clinical trial.



Adding to treatment complexity is the understanding that CD is impacted by the intersection of age, sex, and race, reflecting the interaction between sociocultural, environmental, and genetic factors impacting the development of CD (Barnes et al. 2021; Sedano et al. 2022).Within CD clinical trials, the examination of age, sex, and race from an intersectionality approach has yet to be conducted. An intersectionality approach conceptualizes and acts on complex social inequalities that emerge from the entangled social identities. While calls for the inclusion of an intersectionality approach to clinical trials, and clinical science as a whole (Buchanan and Wiklund, 2020), very few studies have taken such an approach to the analysis of clinical trial data. As such, there is limited evidence on the impact of intersectional personal characteristic on treatment response in CD. "
  ["project_specific_aims"]=>
  string(1172) "1. Assess differences in treatment effect in patients with and without a prior surgical resection.

2. Assess differences in treatment effect in patients with prior treatment failure compared with prior treatment intolerance to biologics.

3. Assess differences in treatment effect among patients with differing disease locations (ileal, colonic, ileocolonic).

4. Assess differences in treatment effect based on use of concomitant medications (corticosteroids, immunomodulators, 5-aminosalicylates, proton pump inhibitors, histamine receptor antagonists, antidepressants, opiates, and antibiotics).

5. Assess whether differences in treatment efficacy differ based on the intersection of age, sex, and race.

6. Examine the impact of each priory history and concomitant medication on individual symptoms of stool frequency & rectal bleeding, changes in c-reactive protein levels & changes in fecal calprotectin levels.

7. Assess the risk of infections and adverse events based on exposure to each concomitant medication.

8. Assess whether differences in treatment safety differs based on the intersection of age, sex, and race."
  ["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(882) "This is an individual participant data (IPD) meta-analysis to assess whether the response and remission differ based on prior clinical history or patient-related characteristics 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 inclusion or exclusion criteria and all individuals within each requested clinical trial will be included.



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

NCT00077779

NCT00055497

NCT00445939

NCT00445432

NCT00348283

NCT02611817

NCT02038920"
  ["project_main_outcome_measure"]=>
  string(1274) "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). We will examine four different primary outcomes, each examined at the primary endpoint assessment period. Different criteria will be examined based on the literate and dichotomized as Presence/Absence. The primary outcomes are:

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

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

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

4. Endoscopic remission:  SES-CD/CDEIS ≤4 / ≤2 

Secondary outcomes are changes in c-reactive protein,  fecal calprotectin, albumin, and presence of infections and adverse events.



Secondary outcomes will be:

1. Baseline and change in C-reactive protein (CRP).

2. Baseline and change in Fecal calprotectin (FCP)."
  ["project_main_predictor_indep"]=>
  string(581) "Prior surgery (presence/absence)

Prior exposure to non-TNF biologics vs anti-TNF (presence/absence)

Number of prior advanced therapies exposures (biologics or small molecules) (0, 1, 2, 3+)

Type of prior exposure – primary non-response (presence/absence) vs secondary loss of response (presence/absence) vs intolerance

Disease location (ileal, colonic, ileocolonic)

Concomitant medications: corticosteroids, immunomodulators, 5-aminosalicylates, proton pump inhibitors, histamine receptor antagonists, antidepressants, opiates, and antibiotics."
  ["project_other_variables_interest"]=>
  string(245) "To examine the intersection of age, sex, and race the following variables will be used as effect-measure modifiers: Age, Sex, and Race. Age will be categorized as 20mg per day, None), levels of albumin, fecalcalprotectin, and C-reactive protein."
  ["project_stat_analysis_plan"]=>
  string(4038) "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) across different concomitant medication exposure (presence vs. absence). 



Treatment effect modification by type of treatment will be assessed. Both unadjusted and adjusted risk ratios will be estimated by the modified Poisson regression approach with and without patient characteristics. The requested data will allow us to answer our study question by allowing us to complete the pooled proportions using the patient-level data.



We will analyze individual level data using the modified Poisson regression to quantify effect modification of a new drug by patient prior history (presence or absence of prior surgical resection, intolerance, failure, type of concomitant medication, and by disease location: ileal, colonic, ileocolonic) on the risk ratio scale (Zou 2004). Safety will be assessed by risk of infection, coded using the Medical Dictionary for Regulatory Activities and summarized by System Organ Class and preferred terms, and risk of serious adverse events. Study-specific estimates and the 95% two-sided confidence intervals will be obtained for outcomes of interest (clinical and endoscopic remission and response). 



To maintain the structure and independence of the requested studies, we will keep each study as a separate file. When pooling the results of the studies into a single dataset for the meta-analysis, we will create a variable that uniquely identifies each study.



To obtain overall estimates and 95% confidence intervals of all studies (pooled analyses), we will apply the extended modified Poisson regression model (Zou et al., 2013) with studies being considered as clusters. A study ID variable will be included as a random effect and this will allow for adjustment of the correlation of individuals within a study and allow for proper estimation of error and confidence intervals. 

The same analyses will be performed by for risk of infection and risk of adverse effects.



Exploration of the intersection of age, sex, and race under an intersectional framework will be examined using multilevel analysis of individual heterogeneity and discriminatory accuracy (MAIHDA). In traditional regression models, the effects of age, sex, and race are assumed to be additive and violations of this assumption may underestimate any intersectional effects (Gagne and Veestra, 2017; Ickert et al. 2021). MAIDHA allows an examination of how an intersectional strata contributes to between stratum variance and avoids violating assumptions of additivity (Evans et al. 2024). Differences between stratum variance indicates a different efficacy of treatment across stratums, an indicator of treatment inequality. Under this framework, level 2 units are the intersections of age, sex, and race, and the level 1 units are individual respondents. A third level representing each trial will be included to adjust for trial-specific bias. Here, each trial represents a unique cluster at the highest level of the model. Intersectional predicted probabilities will produced in the presence of intersectionality. 



For the secondary outcomes from baseline to primary endpoint assessment, log-transformed endpoint C-reactive protein  and fecalcalprotectin will be analyzed using regression models with independent variables, including baseline levels, treatment indicators, and patient characteristics. All analyses will be adjusted for age, sex, race, and disease duration. Results will be reported in terms of treatment effects (mean differences in scores) based on patient prior history exposures, as well as differences in treatment effects between groups. Two-sided 95% confidence intervals and associated p-values will be presented. 



Analyses will be conducted as complete cases, excluding those with missing information."
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
    }
  }
  ["project_timeline"]=>
  string(185) "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(2695) "

Buchanan NT, Wiklund LO. Why Clinical Science Must Change or Die: Integrating Intersectionality and Social Justice. Women & Therapy 2020;43:309–329


Barnes EL, Loftus EV, Kappelman MD. Effects of race and ethnicity on diagnosis and management of inflammatory bowel disease. Gastroenterol. 2021;160:677-689.


De Cruz P, Kamm MA, Hamilton AL, et al. Crohn’s disease management after intestinal resection: a randomized trial. The Lancet. 2015; 385:1406-1417.


Evans CR, Leckie G, Subramanian SV, Bell A, Merlo J. A tutorial for conducting intersectional multilevel analysis of individual heterogeneity and discriminatory accuracy (MAIHDA). SSM – Population Health. 2024;26.


Gagné T, Veenstra G. Inequalities in hypertension and diabetes in Canada: Intersections between racial identity, gender, and income. Ethn Dis. 2017;27: 371


Gisbert JP, Marin AC, McNicholl AG, Chaparro M. Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed. Aliment Pharmacol Ther. 2015;41:613-623.


Global Burden of Disease 2017 Inflammatory Bowel Disease Collaborators. 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 Gastroenterol & Hepatol. 2020; 5:17-30.


Ickert C, Senthilselvan A, Jhangri GS. Multilevel modeling of health inequalities at the intersection of multiple social identities in Canada. The Sociological Quarterly. 2021;0: 1–33


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.


Sedano R, Hogan M, Mcdonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of minorities and underreporting of race and ethnicity in Crohn’s disease clinical trials. Gastroenterol. 2022;162:338-340.


Zou G. A modified poisson regression approach to prospective studies with binary data. American journal of epidemiology. 2004; 159:702–706.


Zou GY, Donner A. Extension of the modified Poisson regression model to prospective studies with correlated binary data. Statistical methods in medical research. 2013; 22:661–670.

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