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  ["project_title"]=>
  string(89) "Impact of Concomitant Steroid Use on Adverse Events in Ulcerative Colitis Clinical Trials"
  ["project_narrative_summary"]=>
  string(685) "Ulcerative colitis (UC) is a chronic condition causing inflammation in the colon, leading to symptoms like diarrhea, bleeding, and pain. Treatment often involves biologics (e.g., infliximab, vedolizumab) and small molecules (e.g., tofacitinib), especially when corticosteroids alone aren't effective. Corticosteroids help with short-term symptoms but can cause serious long-term side effects like infections and cancer. This study will analyze data from several clinical trials to see if continuing steroid use alongside biologics increases these risks. Adverse event rates will be compared between patients who used steroids and those who stopped or never used them during the trials."
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(7) "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(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
  ["project_key_personnel"]=>
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    [0]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(5) "Hasan"
      ["p_pers_l_name"]=>
      string(5) "Hamam"
      ["p_pers_degree"]=>
      string(8) "MD, MSc "
      ["p_pers_pr_affil"]=>
      string(25) "Hamilton Health Sciences "
      ["p_pers_scop_id"]=>
      string(11) "57210187757"
      ["requires_data_access"]=>
      string(3) "yes"
    }
    [1]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(5) "Emily"
      ["p_pers_l_name"]=>
      string(4) "Wong"
      ["p_pers_degree"]=>
      string(4) "BHSc"
      ["p_pers_pr_affil"]=>
      string(24) "Hamilton Health Sciences"
      ["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(1721) "Background:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease causing symptoms like diarrhea, rectal bleeding, and abdominal pain. While biologics and small molecules are advanced treatments, corticosteroids are still used for acute relief. However, long-term steroid use is linked to serious adverse events (AEs).



Objective:

To determine if ongoing corticosteroid use during maintenance therapy in UC patients increases the rate of adverse events compared to those who stop or never use corticosteroids.



Study Design:

Post-hoc analysis of participant-level data from multiple placebo-controlled clinical trials (GEMINI 1, ULTRA 2, OCTAVE-1, VARSITY, ACT 1, and PURSUIT).



Participants:

Patients categorized by corticosteroid use at baseline and during maintenance therapy, including those who continued, stopped, or never used corticosteroids.



Primary and Secondary Outcome Measure(s):

Primary Outcome: Incidence of adverse events in baseline corticosteroid users vs. non-users.

Secondary Outcome: Incidence of adverse events among baseline corticosteroid users who achieved steroid-free remission at one year vs. those who did not.



Statistical Analysis:

Univariate analyses will identify covariates for adverse events, with significant variables (p < 0.05) included in a multivariate model. Logistic regression will evaluate corticosteroid impact on AEs. Continuous variables will be reported as means/medians, and dichotomous variables as proportions/percentages. Statistical significance is set at p < 0.05. Data analysis will use Stata IC 15.0 on the Vivli secure platform."
  ["project_brief_bg"]=>
  string(1967) "Ulcerative colitis (UC) is a chronic, bowel disease that causes inflammation in the colon, the part of the digestive system that stores and processes waste. Symptoms of UC involve diarrhea, bleeding from the rectum, and stomach pain. For some people, these symptoms are so severe that they need stronger treatments. These treatments include biologic drugs and small molecule therapies.



Biologics are a type of drug made from living cells and can help reduce inflammation. Examples are infliximab, vedolizumab, and adalimumab, and clinical trials have shown they can be very effective. Small molecules such as tofacitinib are another option. Both biologics and small molecules have changed the way doctors treat UC.



Another common treatment is corticosteroids, which can help manage UC flare-ups, but they have side effects if used for a long time. These side effects can include infections, cancer, and other serious problems. Researchers are concerned about what happens when corticosteroids are used along with biologics or other immune-suppressing drugs. Current literature lacks direct comparisons on whether people with UC who use corticosteroids along with biologic treatments have more side effects compared to those who don’t use corticosteroids. This study aims to fill this gap by evaluating whether ongoing corticosteroid use during maintenance therapy correlates with higher Adverse Event (AE) rates compared to patients who cease corticosteroids or never used them.



The primary objective of this study is to evaluate whether patients who continue to use corticosteroids during maintenance within clinical trials have a higher rate of AEs compared to those who stopped corticosteroids and those not using steroids.

To do this, we are requesting detailed patient information from several clinical trials: ULTRA 2, GEMINI 1, VARSITY, and OCTAVE-1 from Vivli, and ACT 1 and PURSUIT from the YODA Project."
  ["project_specific_aims"]=>
  string(360) "This study aims to assess the impact of corticosteroid use on AE rates in UC patients receiving biologic therapy. We hypothesize that UC patients continuing corticosteroids during maintenance therapy experience higher AE rates compared to those who were not using steroids at study entry, or those who discontinue corticosteroids successfully during the trial."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(1) {
    [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"
    }
  }
  ["project_research_methods"]=>
  string(637) "Data Source:

The following studies will be used for data analysis: GEMINI 1 (NCT00783718), ULTRA 2 (NCT00408629), OCTAVE-1 (NCT01465763), VARSITY (NCT02497469), ACT 1 (NCT00036439), and PURSUIT (NCT00488631). The studies will be obtained from the YODA and VIVLI platforms. Data analysis will be conducted using STATA on the VIVLI secure platform.



Inclusion Criteria:

- Patients diagnosed with ulcerative colitis.

- Availability of complete data on corticosteroid use and adverse events.



Exclusion Criteria:

- Patients with incomplete data on corticosteroid use or adverse events."
  ["project_main_outcome_measure"]=>
  string(564) "The primary outcome of interest is comparing the incidence of AE between patients using corticosteroids at baseline vs non-steroid users. Then, among baseline corticosteroid users, incidence of AE will be compared between those who achieved steroid-free clinical remission at one-year vs those who were not able to either wean off corticosteroids or achieve clinical remission at one-year assessment. Steroid-free clinical remission is defined as the absence of corticosteroid use at the one-year assessment with a total Mayo Score of ≤2 with no subscore > 1."
  ["project_main_predictor_indep"]=>
  string(64) "The independent variable is the corticosteroid use at baseline. "
  ["project_other_variables_interest"]=>
  string(618) "Demographics (age, sex, race, weight, etc.), disease characteristics (total Mayo score and endoscopic Mayo score), previous therapies (immunomodulators and TNF inhibitors), AE severity (mild, moderate, and severe), and types of AEs (infection, colitis exacerbation, headache, upper respiratory tract infection, nasopharyngitis, anemia, and arthralgia). Univariate analyses will also be conducted to evaluate associations that may exist between covariates (e.g. sex, age, disease duration, etc.) and the outcome of interest. Variables found to have an association (p<0.05) will be included in the multivariate model."
  ["project_stat_analysis_plan"]=>
  string(1730) "This is a post-hoc analysis of data from five clinical trial programs. Descriptive statistics will be provided for each comparison. Logistic regression will be used to assess the corticosteroids' effect 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.



Continuous variables will be presented as means [and standard deviations (SD)] or medians [and interquartile ranges (IQR)]. Dichotomous variables will be summarized as proportions or percentages. The patient pool will be grouped into those who used corticosteroids at baseline and those who did not. Then, among those who used corticosteroids at baseline, these participants will be further categorized into those who achieved steroid-free clinical remission at one year and those who were not able to wean off steroids or achieve steroid-free clinical remission at one year. The AEs will be grouped based on severity as determined by local investigators and reported within the clinical trial: mild, moderate, and severe. The most frequent AEs from each group will also be noted. Statistical significance is chosen to be at p < 0.05. Data will be analyzed using Stata IC 15.0, which is available on the Vivli secure platform.



In this analysis, any missing data will be excluded. This decision is based on the aim to ensure the integrity and accuracy of the findings. By excluding missing data, we acknowledge the potential limitation that the sample size may be reduced, but this approach prevents the introduction of bias that could occur through imputation methods."
  ["project_software_used"]=>
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    [0]=>
    array(2) {
      ["value"]=>
      string(5) "stata"
      ["label"]=>
      string(5) "STATA"
    }
  }
  ["project_timeline"]=>
  string(84) "Target Analysis Start Date: 9/1/24

Estimated Analysis Completion Date: 9/1/25"
  ["project_dissemination_plan"]=>
  string(743) "Anticipated products include abstracts and posters, which may be presented at scientific meetings such as Canadian Digestive Diseases Week, Digestive Disease Week, and European Crohn’s and Colitis Organization. A manuscript is expected to result from this study and will be submitted to peer-reviewed journals such as Gastroenterology, American Journal of Gastroenterology, and Clinical Gastroenterology and Hepatology. All products resulting from this research project, which may include abstracts, manuscripts, posters, and slide decks will be shared with Vivli at least 30 days prior to the time of submission or public disclosure.

Target audiences include clinicians and researchers with an interest in inflammatory bowel disease."
  ["project_bibliography"]=>
  string(1721) "
1. Troncone E, Monteleone G. Expert Opinion on Drug Safety The safety of non-biological treatments in Ulcerative Colitis The safety of non-biological treatments in Ulcerative Colitis. 2017 [cited 2024 Feb 12]; Available from: https://www.tandfonline.com/action/journalInformation?journalCode=ieds20
2. Bouguen G, Levesque BG, Feagan BG, Kavanaugh A, Peyrin-Biroulet L, Colombel JF, et al. PERSPECTIVES IN CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Treat to Target: A Proposed New Paradigm for the Management of Crohn’s Disease. 2015 [cited 2024 Feb 12]; Available from: http://dx.doi.org/10.1016/j.cgh.2013.09.006
3. Danese S, Panés J. Development of Drugs to Target Interactions Between Leukocytes and Endothelial Cells and Treatment Algorithms for Inflammatory Bowel Diseases. Gastroenterology. 2014 Nov 1;147(5):981–9. 
4. Stallmach A, Hagel S, Bruns T. Adverse effects of biologics used for treating IBD. Best Pract Res Clin Gastroenterol. 2010 Apr 1;24(2):167–82. 
5. Shah ED, Farida JP, Siegel CA, Chong K, Melmed GY. Risk for Overall Infection with Anti-TNF and Anti-integrin Agents Used in IBD: A Systematic Review and Meta-analysis. Inflamm Bowel Dis [Internet]. 2017 Apr 1 [cited 2024 Feb 14];23(4):570–7. Available from: https://dx.doi.org/10.1097/MIB.0000000000001049
6. Kirchgesner J, Lemaitre M, Carrat F, Zureik M, Carbonnel F, Dray-Spira R. Risk of Serious and Opportunistic Infections Associated With Treatment of Inflammatory Bowel Diseases. Gastroenterology. 2018 Aug 1;155(2):337-346.e10. 
7. Toruner M, Loftus E V, Scott Harmsen W, Zinsmeister AR, Orenstein R, Sandborn WJ, et al. Risk Factors for Opportunistic Infections in Patients With Inflammatory Bowel Disease. 2008;

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data partner
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pi country
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}


pi affil
array(1) {
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}


products
array(3) {
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num of trials
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}


res
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}


                

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6. Kirchgesner J, Lemaitre M, Carrat F, Zureik M, Carbonnel F, Dray-Spira R. Risk of Serious and Opportunistic Infections Associated With Treatment of Inflammatory Bowel Diseases. Gastroenterology. 2018 Aug 1;155(2):337-346.e10. 
7. Toruner M, Loftus E V, Scott Harmsen W, Zinsmeister AR, Orenstein R, Sandborn WJ, et al. Risk Factors for Opportunistic Infections in Patients With Inflammatory Bowel Disease. 2008;