View clinical trials related to Crohn's Disease.
Filter by:Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.
Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.
Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by relapse and progression. The incidence and prevalence of IBD are increasing in different regions around the world, indicating its emergence as a global disease. Though modern medical therapies including immunomodulators and biologic agents have revolutionized treatment of CD, the occurrence of steroids-dependence and resistance or intolerance to medical therapy is quite common. The limitation of present therapeutic management and the high expense of biologic agents leads to the treatment of CD become "refractoriness". The occurrence rate of steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the management of such refractory CD remains a great therapeutic challenge for clinicians. Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis factor)-a- suppressing effects. The potential role for thalidomide in the treatment of refractory paediatric and adult CD has been investigated in more and more small open-label studies and retrospective case series. Recently, a randomized controlled trial showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a median of 58 months. However, the dose of thalidomide used in these studies ranged from 50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite high. The side effects related to the dose of thalidomide were the major concerns of using it in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing which is a more objective and important outcome in CD was rarely reported. Therefore the aim of this study is to investigate the efficacy on clinical and endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD patients.
This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.
Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free, low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a small number of recent studies have looked at change in bowel wall thickness (BWT) in response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to detect response to anti-TNF therapy has not been tested in pediatric patients. The purpose of this study is to apply the use of SBUS to pediatric patients with Crohn's disease and to assess response to treatment with infliximab. The investigators will also measure C-reactive protein and fecal calprotectin at baseline, and additionally measuring IFX levels and anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment, as well as correlation between these markers with changes in patient reported outcomes via a weighted pediatric Crohn's disease activity questionnaire (wPCDAI) and changes in BWT. This study is novel in that it will be the first study in pediatric patients to use SBUS to assess response to IFX therapy, and will also be the first study to correlate SBUS findings with therapeutic drug monitoring (TDM). This study has the potential to propagate the use of SBUS in the pediatric population, as the use of TDM in concert with small bowel imaging post-induction will allow the investigators to tailor therapy early in the treatment course.
Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.
The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.
This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease
In this research proposal, the investigators will focus on methods to optimize the therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study will also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX with dendritic cells in both healthy subjects and patients with Crohn's disease (proliferation, maturation, cytokine profile, apoptosis, gene expression).
The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.