Active clinical trials for "Crohn Disease"

The purpose of this is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention.

The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and possibly additional examinations including endoscopy and imaging; any of these steps of the diagnosis can only be replaced by another. In the absence of data in the literature on the evaluation of specific LAP Crohn inspection, Clemence Horaist et al established definitions of these lesions inspection with the help of an expert group, then evaluated the diagnostic agreement LAP these definitions in the same group from a selection of photographs. Definitions ulceration, fistula, inflammatory external os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70) The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014. The interns Hepato gastroenterology must learn during their training to know the terminology of LAP Crohn inspection and to recognize so considered acceptable by experts.

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.

Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17 cells and other immune cell types) or biomarkers can be used to predict the response or lack of response to treatment with Infliximab. If so, characteristics of the immune cells may also unveil the mechanisms behind lack of response to Infliximab. Design: a prospective, observational study with three arms. In the treatment group, 35 patients with Crohn's disease about to start Infliximab-treatment are recruited. They have blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines, and data from this study is not used by the clinicians. Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is investigated using flow cytometry. From plasma and serum samples, various proteins (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical history) are extracted from various registries.

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery. By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases. If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.

The primary objective of this study is to evaluate sustained clinical remission (for the definition see below) in patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab. Secondary objectives include: to identify predictors of sustained clinical remission during long-term infliximab scheduled treatment to identify predictors of loose of response during infliximab scheduled maintenance treatment to identify predictors for maintaining clinical remission in patients who discontinue infliximab because of long-lasting steroid-free clinical remission to evaluate percentage of surgery during and after treatment (total follow-up) to evaluate safety of long-term infliximab scheduled treatment List the clinical hypotheses Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease patients who not tolerate or are not responsive to conventional therapies. Most of randomized clinical trials about the use of infliximab in inflammatory bowel diseases are limited to 52 weeks and very few data come from some observational studies about results of prolonged (over one year) treatment with infliximab. No validated predictors of sustained clinical remission or loss of response are available so far. Moreover, few data are available about the hypothetical reduction of IBD related surgery in the "biological era". In this proposal we suggest the following hypotheses: infliximab scheduled treatment may be efficacious in maintain long-term clinical remission; among clinical, laboratory and endoscopic data some predictors of sustained clinical remission during infliximab long-term scheduled treatment may be found; among clinical, laboratory and endoscopic data some predictors of loss of response during infliximab long-term scheduled treatment may be found; among clinical, laboratory and endoscopic data some predictors of sustained clinical remission after infliximab discontinuation because of long-lasting (> 6 months) steroid-free clinical remission may be found; maintenance of remission with infliximab may reduce rates of surgery over time; long-term scheduled treatment with infliximab may be safe and well tolerated. Results from this study may really help clinicians to make practical decisions in these particular clinical settings.

This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence. Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks. Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks. The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.

A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or control product (N=56) during one year.