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      ["post_title"]=>
      string(134) "NCT01863771 - A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis"
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  ["property_scientific_abstract"]=>
  string(2516) "Background: The placebo response in clinical trials is a complex phenomenon that is influenced by multiple factors including the type of intervention, the method and frequency of treatment, response expectancy, patient-provider interactions, behavioral conditioning, and the clinical context.1-3 Understanding the factors associated with the placebo response in inflammatory bowel disease (IBD) trials is crucial for designing efficient clinical trials and interpretation of trial results. Access to subject-level data from the placebo arms of multiple  Ulcerative colitis (UC) and Crohn?s disease (CD) trials would allow a rigorous assessment of placebo rates and subject-level factors associated with the placebo response.

Objective: The primary objective of this study is to estimate the placebo clinical response and remission rates in induction and maintenance periods of CD and UC trials and identify factors influencing these rates. The secondary objectives of this study are to estimate the response and remission rates in induction and maintenance periods of CD and UC trials and identify factors influencing these rates.

Study Design: This study is an individual participant or patient data (IPD) meta-analysis to investigate factors affecting placebo rates in IBD randomized controlled trials (RCTs) while minimizing bias arising from the heterogeneity of analyzing protocols between trials. IPD will be obtained for subjects randomized to the placebo group in published phase 2 and 3 induction and maintenance RCTs evaluating the safety and efficacy of biologics and small molecule drugs in moderately to severely active CD and UC. Studies were identified by systematic review of all phase 2 and phase 3 trials from the last 10 years (2010-present). IPD will be obtained and subject, disease, clinical, and trial characteristics that may be associated with a placebo response in clinical and endoscopic disease activity will be identified for induction and maintenance trials. 

Participants: UC and CD patients

Main Outcome Measures: The following will be reported for the baseline (Week 0) and primary endpoint assessment visits for both induction and maintenance periods: Mayo Clinic Score, Geboes Score, Robarts Histopathology Index score for UC and CD Activity Index, Endoscopic Score for CD.

Statistical Analysis: Statistical analyses will be performed using a complete-case analysis. We will be doing either one stage or two stage or both stage IPD meta-analysis."
  ["project_brief_bg"]=>
  string(1396) "IBD is a chronic inflammatory condition of the digestive tract affecting 6.8 million people worldwide.4 UC is a type of IBD that affects the inner lining of the colon and the rectum and leads to disability. In CD, another type of IBD, inflammation can affect multiple layers of all parts of the digestive tract and leads to both disability and bowel damage. The global burden of both types of IBD has continued to increase, and treatment options are expanding as additional therapies undergo clinical development.

In RCTs of IBD therapies conducted to date, improved outcomes after receiving placebo are well recognized (ie, the placebo effect).5 These placebo effects limit the ability to fully understand any treatment benefits. Previous systematic reviews and meta-analyses have pooled the placebo results of IBD studies and identified several trial-related factors associated with the placebo effect such as disease activity of the population at the start of the trial. 3; 6-7 However, thorough assessment of the placebo effect using both trial-related data and individual participant data is needed to further improve the design and understanding of future IBD clinical trials. The aims of the current study are to estimate placebo response and remission rates in UC and CD trials and to identify the trial-related and participant-related factors that influence these placebo effects."
  ["project_specific_aims"]=>
  string(1304) "Determining the subject- and trial-level factors that influence placebo response, non-response, and hyper-response in IBD clinical trials may help to inform the design and efficiency of future clinical trials in UC and CD. This will be accomplished by collecting anonymized IPD from placebo arms of RCTs published within the past 10 years, as these trials were most likely designed to meet recent contemporary regulatory guidelines (e.g. use of centralized endoscopy),8-10 performed more extensive outcome analyses (e.g., patient-reported, histological, and biochemical analyses),11, 12 and enrolled subjects more closely resembling the current IBD population.13

The primary objective of this study is to estimate the placebo clinical response and remission rates in induction and maintenance periods of CD and UC trials and identify factors influencing these rates. The secondary objectives of this study are to estimate the response and remission rates (including endoscopic, histologic, and clinical based definitions) in induction and maintenance periods of CD and UC trials and identify factors influencing these rates.

Since meta-analyses are not hypothesis-testing activities, there is no specific hypothesis. We hope to increase the precision of the estimates for the placebo rates."
  ["project_study_design"]=>
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  }
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  ["project_research_methods"]=>
  string(998) "A search of MEDLINE (1948-January 2020), EMBASE (1947-January 2020), the Cochrane Central Register of Controlled Trials (2020), and the Cochrane IBD/Functional Bowel Disorders review group specialized trials register was performed without language restriction from inception to January 2020 for all published induction and maintenance RCTs in CD and UC. Published trials were reviewed to identify all RCTs published since 2010, evaluating the safety and efficacy of biologics or small molecule drugs for moderately to severely active CD and UC. Data will be extracted from the RCTs identified by our search.

The data from the Yoda Platform will be combined with the studies from the Vivli Platform. Please see the rest of the studies that we will be including in the analysis below;

NCT00445939

NCT00445432

NCT02499783

NCT00385736

NCT00408629

NCT00853099

NCT00783718

NCT00783692

NCT01224171

NCT02039505

NCT02038920"
  ["project_main_outcome_measure"]=>
  string(1287) "The following will be reported for the baseline (Week 0) and primary endpoint assessment visits for both induction and maintenance periods:

UC Trials:

1.	Mayo Clinic Score (MCS) (median, interquartile range (IQR))

2.	Each subcomponent of the MCS (median, IQR)

3.	Change in the total MCS score and change in each subcomponent of the MCS

4.	Geboes Score (median, IQR)

5.	Change in Geboes Score

6.	Robarts Histopathology Index (RHI) score (calculated from Geboes subscores, if available) (median, IQR) Change in RHI score

CD Trials:

1.	Crohn?s Disease Activity Index (CDAI) (mean, standard deviation (SD), median, IQR)

2.	Each subcomponent of the CDAI, if available

3.	Change in the total CDAI from baseline and change in each component of the CDAI

4.	2-item patient-reported outcome (PRO2), if stool frequency (SF) and abdominal pain (AP) subscores of the CDAI are available (median, IQR)

5.	Change in PRO2 scores

6.	Simple Endoscopic Score for Crohn?s Disease (SES-CD)/ Crohn?s Disease Endoscopic Index of Severity (CDEIS) (median, IQR)

7.	Each subcomponent of the SES-CD/CDEIS, per segment

8.	Change in total SES-CD/CDEIS score and change in each component of the SESCD/CDEIS"
  ["project_main_predictor_indep"]=>
  string(579) "The following outcomes will be collected for both UC and CD trials. Their definitions will be taken directly from their respective trial.

Remission

1)	Clinical Remission

2)	Endoscopic Remission

3)	Histologic Remission

4)	Sustained Clinical Remission

5)	Corticosteroid-free Clinical Remission

6)	Sustained Corticosteroid-free Clinical Remission

Response

1)	Clinical Response

2)	Endoscopic Response

3)	Histologic Response 

Please see the attached Extraction sheet for other Variables of Interests."
  ["project_other_variables_interest"]=>
  string(41) "Please see the attached Extraction sheet."
  ["project_stat_analysis_plan"]=>
  string(3985) "This study is an IPD meta-analysis to investigate factors affecting placebo rates in IBD RCTs while accounting for heterogeneity between trials. IPD will be conducted using data for individual subjects randomized to the placebo group in published phase 2 and 3 induction and maintenance RCTs evaluating the safety and efficacy of biologics and small molecule drugs in moderately to severely active CD and UC. Studies were identified by systematic review of all phase 2 and phase 3 trials from the last 10 years (2010-present). List of variables are attached for the data extraction. IPD will be obtained and subject, disease, clinical, and trial characteristics that may be associated with a placebo response in clinical and endoscopic disease activity will be identified (Extraction sheet is attached) for induction and maintenance trials.

Statistical analyses will be performed on the data received, using a complete-case analysis. Depending on the severity of missing data, we will attempt to use multiple imputation as a sensitivity analysis. Raw data for end of treatment visits will be collected, as opposed to scores derived by imputation methods (e.g., last observation carried forward, etc). If an imputation method was used to determine the end of treatment score for a subject, the subject should be flagged in the database. We will be doing either one stage or two stage or both stage analysis IPD meta-analysis. For one stage analysis the trials data will be combined and then analysis will be performed. Two stage analysis will entail obtain summary statistics first, followed by aggregating results from stage one.

Summary statistics will be used to describe study and individual participant characteristics for data obtained from the CD and UC trials. Baseline/ demographic characteristics, disease activity measures, and improvement in disease activity indices rates will be analyzed using the combined data, separately, for induction, maintenance phases and study-subgroup analyses of trials. Point estimates and associated 95% confidence intervals [CIs] will be reported.

In the one-stage analysis, generalized linear mixed-effects approach will be used to identify the factors (Baseline/ demographic characteristics and disease activity measures) associated with the placebo response/remission rates using the various definition and the study-subgroups. The final model for each outcome will be based on Bayesian information criterion. Adjusted proportions will be obtained from the final model with independent variables centered. 

In the two-stage analysis, proportions from all studies will be pooled using conventional meta-analysis methods. This data will also be used to investigate how characteristics of studies may affect study aggregate. For meta-regression analyses, Disease activity measures variables and the baseline/demographic characteristics variables will be used as the factors. Mixed-effects meta-regression will be used to assess the effect of each study-level characteristic on placebo rates. Random-effects model will be chosen to account for both between- and within-study variability. Point estimates and associated 95% CIs will be reported.

Continuous factors will be centered and unadjusted estimates (95% confidence intervals) for outcome proportions obtained, as well as estimates adjusted by important factors. Estimates will be presented as odds ratios (ORs) with P-values.  Factors with P-values less than 0.1 in univariate meta-regression will be selected to multivariable meta-regression analysis. To combine the results from different platforms the estimates from all studies will be pooled as conventional meta-analysis using two stage approach. 

In order to maintain the structure and independence of the studies being requested, each study will be kept as a separate file. When combining the studies into a single dataset, we will create a variable that uniquely identifies each study."
  ["project_timeline"]=>
  string(320) "1 Dec 2021 ? 30 Nov 2024

?	Project start date: 1 Dec 2021

?	Analysis completion date: 1 June 2023

?	Manuscript drafted: 1 Oct 2023

?	Manuscript submitted for publication: 1 March 2024

?	Results reported back to the YODA Project: 1 Sept 2024

?	Project completion date: 1 Dec 2024"
  ["project_dissemination_plan"]=>
  string(728) "We anticipate that the analysis will result in a manuscript in a clinical gastroenterology journal, we also anticipate the sharing of the resulting information through presentation at relevant international conferences (e.g., Digestive Disease Week, and the European Crohn?s and Colitis Organization Congress). The results from this study will have several stakeholders. The immediate target audience are those involved in designing clinical trials (primarily researchers, investigators, and industry). Information gleamed on factors effecting placebo rates could help design studies such that the efficacy of new therapeutics can be realized and lead to new and improved treatment options for the unmet need for these diseases."
  ["project_bibliography"]=>
  string(3969) "
1. Hindryckx P, Baert F, Hart A, Magro F, Armuzzi A, Peyrin-Biroulet L, et al. Clinical trials in ulcerative colitis: a historical perspective. J Crohns Colitis. 2015 Jul;9(7):580-8.

2. Su C, Lewis JD, Goldberg B, Brensinger C, Lichtenstein GR. A meta-analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis. Gastroenterology. 2007 Feb;132(2):516-26.

3. Jairath V, Zou GY, Parker CE, MacDonald JK, AlAmeel T, Al Beshir M, et al. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. Cochrane Database Syst Rev. 2017 Sep 8;9:CD011572.

4. 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

5. Elsenbruch, S., Enck, P. (2015). Placebo effects and their determinants in gastrointestinal disorders. Nature Reviews Gastroenterology & Hepatology, 12(8), 472-485. https://doi.org/10.1038/nrgastro.2015.117

6. Jairath, V., Zou, G.Y., Parker, C.E., MacDonald, J.K., Mosli, M.H., AlAmeel, T., Al Beshir, M., Almadi, M., Al-Taweel, T., Atkinson, N.S., Biswas, S., Chapman, T., Dulai, P.S., Glaire, M.A., Hoekman, D.R., Koutsoumpas, A., Minas, E., Samaan, M., Khanna, R., Leveseque, B.G., D’Haens, G., Sandborn, W.J., Feagan, B.G. (2017). Systematic review with meta-analysis: placebo rates in induction and maintenance trials of Crohn’s disease. Alimentary Pharmacology & Therapeutics, 45(8), 1021-1042. https://doi.org/10.1111/apt.13973

7. Duijvestein, M., Jeyarajah, J., Guizzetti, L., Zou, G., Parker, C.E., van Viegen, T., VandeCasteele, N., Khanna, R., Van Der Aa, A., Sandborn, W.J., Feagan, B.G., D’Haens, G.R., Jairath V. (2020). Response to placebo, measured by endoscopic evaluation of Crohn’s disease activity, in a pooled analysis of data from 5 randomized controlled induction trials. Clinical Gastroenterology Hepatology, 18(5),1121-1132. https://doi.org/10.1016/j.cgh.2019.08.025

8. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Crohn?s disease (revision 2). Published June 28, 2018. Accessed December 27, 2018. Available from: https://www.ema.europa.eu/documents/scientific-guideline/guidelinedevelo….

9. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of ulcerative colitis. Published June 28, 2018. Accessed December 27, 2018. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/….

10. US Food and Drug Administration. Ulcerative colitis: clinical trial endpoints. Guidance for industry (draft guidance). Published August 5, 2016. Accessed March 15, 2017. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat….

11. Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, et al. Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set. Clin Gastroenterol Hepatol. 2018 May;16(5):637-47.

12. Ma C, Hussein IM, Al-Abbar YJ, Panaccione R, Fedorak RN, Parker CE, et al. Heterogeneity in definitions of efficacy and safety endpoints for clinical trials of Crohn’s disease: a systematic review. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1407-19.

13. Targownik LE, Tennakoon A, Leung S, Lix LM, Singh H, Bernstein CN. Temporal trends in initiation of therapy with tumor necrosis factor antagonists for patients with inflammatory bowel disease: a population-based analysis. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1061-70 e1.
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products
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num of trials
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}


res
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}