Ulcer Healing Analysis for Inflammatory Bowel Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Terrence A Barrett
Must be taking: Anti-TNF therapy
Must not be taking: Anticoagulants, Anti-platelets, Steroids, Metformin
Disqualifiers: Pregnant, HIV positive, Stroke, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial involves taking small pieces of tissue from the colon to study how ulcers heal. It includes patients with inflammatory bowel disease, arthritis, and healthy individuals to compare healing processes. Researchers will examine how genes work and how cells produce energy to understand healing.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulants, anti-platelet medications (except low-dose aspirin), steroids, or metformin.
What data supports the effectiveness of the treatment Serial Biopsy, Entyvio, Entyvio Pen for healing ulcers in inflammatory bowel disease?
Research suggests that achieving mucosal healing (healing of the gut lining) in inflammatory bowel disease can lead to better patient outcomes, such as fewer hospital visits and surgeries. Although specific data on Entyvio is not provided, the general evidence indicates that treatments promoting mucosal healing are beneficial.12345
Is the treatment generally safe for humans?
How does the drug Entyvio differ from other treatments for inflammatory bowel disease?
Entyvio (also known as vedolizumab) is unique because it specifically targets the gut by blocking a protein that causes inflammation, which may lead to better mucosal healing (repair of the gut lining) compared to other treatments that affect the entire immune system. This targeted approach can potentially result in fewer side effects and improved outcomes for patients with inflammatory bowel disease.23101112
Eligibility Criteria
This trial is for people with ulcerative colitis or Crohn's disease who haven't responded to or haven't tried biologic treatments, and those with rheumatoid or psoriatic arthritis on anti-TNF therapy. Healthy individuals with normal colonic mucosa can also participate.Inclusion Criteria
I have been diagnosed with ulcerative colitis or Crohn's disease.
I have been diagnosed with rheumatoid or psoriatic arthritis.
I have either not responded to biologic treatment or have never received it.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Biopsy
Biopsies are collected at baseline during standard of care endoscopy
1 day
1 visit (in-person)
Treatment
Participants receive anti-TNF therapy as part of their standard care
5 weeks
Follow-up Biopsy
Biopsies are collected at a follow-up research endoscopy to assess healing
1 day
1 visit (in-person)
Follow-up
Participants are monitored for changes in gene expression and ulcer healing
4 weeks
Treatment Details
Interventions
- Serial Biopsy (Procedure)
Trial OverviewThe study involves taking small tissue samples (biopsies) from the colon at two different times to compare healing processes in patients with IBD against those in healthy controls and arthritis patients.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Rheumatoid/Psoriatic ArthritisExperimental Treatment1 Intervention
Participants in this group will have been diagnosed with rheumatoid (RA) or psoriatic arthritis (PsA) and will be receiving anti-TNF antibody therapy at the time of enrollment.
Group II: Inflammatory Bowel DiseaseExperimental Treatment1 Intervention
Participants in this group will have been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and have either failed treatment with biologics or be naive to biologic therapy.
Group III: Healthy ControlsExperimental Treatment1 Intervention
Participants in this group will be healthy (not diagnosed with inflammatory bowel disease).
Serial Biopsy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Entyvio for:
- Moderate to severe ulcerative colitis
- Crohn's disease
🇪🇺 Approved in European Union as Entyvio for:
- Moderate to severe ulcerative colitis
- Crohn's disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who Is Running the Clinical Trial?
Terrence A BarrettLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Fecal Calprotectin Predicts Relapse and Histological Mucosal Healing in Ulcerative Colitis. [2022]Mucosal healing in ulcerative colitis leads to a decreased need for medication and decreased risk of disease relapse and colectomy. Histological healing seems to improve the disease prognosis even further. An assessment of both endoscopic and histological mucosal healing requires endoscopy, and the need for a reliable noninvasive biomarker to predict disease relapse is obvious.
Mucosal healing as a treatment for IBD? [2022]In the last years mucosal healing has emerged as an important therapeutic goal for patients with inflammatory bowel disease. Growing evidence suggests that mucosal healing can improve patient outcomes and, potentially, can alter the natural course of the disease by inducing sustained clinical remission and reducing hospitalizations and surgery. However several questions remain to be answered. A validated definition of mucosal healing is still lacking and the effect size of different drugs is difficult to assess because of different definitions, different study design, and different timing of endoscopic evaluation. The evidence that mucosal healing has a high positive predictive value for long-term good clinical outcome is still limited and, therefore, mucosal healing remains a weak surrogate end point of disease course. Future studies are needed to develop a standardized definition of mucosal healing and to prospectively assess the impact of mucosal healing on long-term clinical outcomes.
Predictors of tissue healing in ulcerative colitis patients treated with anti-TNF. [2017]To identify factors predicting mucosal healing in ulcerative colitis patients treated with anti-TNFα agents with or without azathioprine.
Clinical aspects of mucosal healing in inflammatory bowel diseases: what is it and what is the real value for the everyday practice? [2015]The course of inflammatory bowel diseases is heterogeneous and varies over time. Therefore, the search for predictive factors has increasingly become the focus of research. Mucosal healing has emerged as an important objective, as evidence indicates that it is associated with improved disease outcome. Nevertheless, many unsolved questions remain, including the definition of complete or partial healing as well as the best assessment method using endoscopic or imaging techniques, most of which are relatively invasive and expensive procedures, which therefore are not ideal for frequent monitoring and it is not clear. This review summarizes the available evidence in order to assist clinicians when assessing the mucosal status in the everyday practice.
Mucosal healing in inflammatory bowel disease. [2022]It is becoming increasingly recognized that purely clinical endpoints may not be sufficient in the treatment of patients with inflammatory bowel disease. As such, mucosal disease assessment has become a prominent component of the majority of recent clinical trials in Crohn's disease and ulcerative colitis. There is mounting evidence that the attainment of mucosal healing leads to improved clinical outcomes in both Crohn's disease and ulcerative colitis. However, the use of mucosal healing as a therapeutic endpoint in inflammatory bowel disease is in its early stages, as a number of issues limit its application to routine clinical practice.
Disease Burden and Patient-Reported Outcomes Among Ulcerative Colitis Patients According to Therapy at Enrollment Into CorEvitas' Inflammatory Bowel Disease Registry. [2023]To evaluate disease burden and patient-reported outcomes (PROs) of ulcerative colitis (UC) patients at enrollment into CorEvitas' Inflammatory Bowel Disease Registry by therapy class.
Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. [2018]We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC).
Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label phase I-II study of tolerance. [2019]Transdermal nicotine provides benefit in active ulcerative colitis but is often associated with adverse events (AEs). An oral formulation has been developed to minimize AEs. This study was undertaken to make initial observations on the safety and tolerance of oral nicotine therapy in inflammatory bowel disease; the effect on disease activity was also noted.
Mucosal Healing in Ulcerative Colitis: A Comprehensive Review. [2022]Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by periods of remission and periods of relapse. Patients often present with symptoms such as rectal bleeding, diarrhea and weight loss, and may require hospitalization and even colectomy. Long-term complications of UC include decreased quality of life and productivity and an increased risk of colorectal cancer. Mucosal healing (MH) has gained progressive importance in the management of UC patients. In this article, we review the endoscopic findings that define both mucosal injury and MH, and the strengths and limitations of the scoring systems currently available in clinical practice. The basic mechanisms behind colonic injury and MH are covered, highlighting the pathways through which different drugs exert their effect towards reducing inflammation and promoting epithelial repair. A comprehensive review of the evidence for approved drugs for UC to achieve and maintain MH is provided, including a section on the pharmacokinetics of anti-tumor necrosis factor (TNF)-α drugs. Currently approved drugs with proven efficacy in achieving MH in UC include salicylates, corticosteroids (induction only), calcineurin inhibitors (induction only), thiopurines, vedolizumab and anti-TNFα drugs (infliximab, adalimumab, and golimumab). MH is of crucial relevance in the outcomes of UC, resulting in lower incidences of clinical relapse, the need for hospitalization and surgery, as well as reduced rates of dysplasia and colorectal cancer. Finally, we present recent evidence towards the need for a more strict definition of complete MH as the preferred endpoint for UC patients, using a combination of both endoscopic and histological findings.
Mucosal healing in inflammatory bowel disease: treatment efficacy and predictive factors. [2022]In recent years mucosal healing has emerged as an important therapeutic goal for patients with inflammatory bowel disease. Growing evidence suggests that achieving mucosal healing can improve patient outcomes and, potentially, alter the course of the disease. Drugs currently used in the management of inflammatory bowel disease are potentially able of inducing and maintaining mucosal healing, but the effect size is difficult to assess because of different definitions of mucosal healing, differences in study designs, and timing of endoscopic evaluation. Mucosal healing has been studied extensively in the biologic era. Data available from different sources, such as controlled trials and observational studies, show that anti-TNFα therapies can induce rapid and sustained mucosal healing in a variable percentage of patients with Crohn's disease and ulcerative colits. No controlled study has been designed to identify possible predictors of mucosal healing. Some clinical characteristics such as extensive disease, young age at diagnosis, and smoking status may be predictive of a more aggressive clinical course and, presumably, of a reduced clinical and endoscopic response to therapy. Changes and normalization of C-reactive protein and faecal calprotectin may be useful tools to predict outcomes, guide the timing for endoscopic evaluation and, possibly, reduce the need of endoscopic evaluation in assessing mucosal healing.
Combined use of CDAI and blood indices for assessing endoscopic activity in ileocolic Crohn's disease. [2023]Mucosal healing has become the primary treatment target for patients with Crohn's disease (CD). We aimed to develop a noninvasive and convenient tool to evaluate the endoscopic activity in patients with ileocolic CD.
Characterisation of Mucosal Healing with Adalimumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: Results from the EXTEND Trial. [2022]Mucosal healing [MH] is an important goal for patients with Crohn's disease [CD], yet is incompletely characterised. We investigated whether MH differed by segments across the colon and ileum in patients who received adalimumab maintenance treatment in the EXTEND study.