Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
Condition: Crohn's Disease; IBD
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United
      States with many of those being young children and adolescents. Physicians need better ways
      to inform decisions on therapy selection and recognize ongoing intestinal injury while on
      treatment.

      The main reason for this research study is to see if a blood test or stool test, which
      measures specific proteins, taken just before starting a new treatment for Crohn's disease
      can predict a patient's ability to achieve complete intestinal healing. The investigators
      also want to see if the intensity of gut inflammation can be detected by measuring a separate
      set of proteins in the blood.
    

Detailed description: 
      Despite the heterogeneity of CD phenotypes and a potentially aggressive course of
      inadequately treated CD, treatment selection for newly diagnosed patients is currently based
      on clinical factors which do not define CD sub-types. Now, with additional biologic therapies
      for CD, there is a critical need for individual biochemical analysis both pre-treatment, and
      following induction to assess the probability of durable remission. These data will inform
      decisions on continued dosing of the current biologic, or whether addition of combination
      therapy or switching to a therapy with an alternative mechanism of action will be more
      beneficial.

      The Food & Drug Administration (FDA) defines a companion diagnostic as a device that can
      identify patients most likely to benefit from a therapy or a device to monitor response with
      the purpose to adjust the treatment to achieve improved effectiveness.Our global aim is to
      develop a companion diagnostic (peripheral blood panel) that accurately predicts the
      probability of deep remission (clinical remission with MH) to anti-TNF and a protein (blood)
      biomarker panel that reproducibly distinguishes endoscopic MH from active (ulcerated)
      intestinal inflammation in patients with CD.

      The long-term strategy is to utilize the "low-risk" anti-TNF specific module (protein panel)
      to personalize CD therapy. With the addition of new biologics for CD, patients with a
      low-risk inflammatory profile would not only be expected to achieve MH but also predicted to
      respond to treatment escalation strategies while avoiding or stopping the drug (if drug
      exposure is optimized) sooner in patients in which the protein profile predicts a low
      probability of deep remission with anti-TNF. As additional therapies are approved for
      pediatric CD, the priority would be to avoid anti-TNF in patients with a "high-risk" protein
      profile and specifically select therapies that target the patient's individual inflammatory
      signature. Additionally, the investigators expect the protein profile of patients failing to
      achieve deep remission to provide further insight into molecular mechanisms contributing to
      the continued inflammation and thereby directing the next therapeutic option.
    

Intervention name(s): Infliximab; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): No standard dosing regimen will be used and the dose will be determined by the treating physician; No standard dosing regimen will be used and the dose will be determined by the treating physician
Other intervention name(s): Remicade; Humira
Intervention MeSH terms: Adalimumab; Infliximab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Potential IBD participants will be recruited through the Division of Gastroenterology at
        each participating site.

        Healthy volunteers will be recruited from through direct advertising methods approved by
        the IRB and formal local databases intended for recruitment.
      
Biospecimen description: 
      -  Blood specimens will be collected for biomarker discovery and validation

        -  Stool specimens will be collected for microbial analysis and additional IBD-related
           stool biomarkers

        -  OPTIONAL: Four additional research-only intestinal pinch biopsies at the time of a
           clinically indicated or research-only colonoscopy