Active clinical trials for "Crohn Disease"

Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients. Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted. Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections. The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool. In the current study the investigators aim to: Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments Identify the predictors and risk factors of mild and moderate infections. Assess the relation between patient reported infections and the risk for serious infectious complications

Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet. The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response. The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects. Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies. The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data. The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab

Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively. The current study is designed to provide a systematic and consistent overview of the real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The data collected in this observational trial will be used to increase the knowledge of the effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with moderate-to-severe CD.

Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.

Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.

This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.

The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is thought to be predictive of a favourable evolution of the disease. However, up to now there is no measure of endoscopic remission, objectively constructed and validated, not even a consensus for its definition. An objective measure of endoscopic remission is necessary, notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and EMA), but also in clinical practice if one wishes to adapt the treatment of patient according to the level of endoscopic remission. The aim of the study is to construct a measure of endoscopic remission based on an objective assessment (depth or grade) of remission, that must be reproducible, little or not dependent on the reader interpreting the endoscopy. The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of the endoscopic remission of CD through an index measuring its depth or a score measuring its grade and to evaluate its reproducibility. This study is composed of four main parts: Training and selection of readers: Selection and definition of all lesions to be studied at consensus meetings, first between the central readers, then with the participation of local investigators. Specific training of local investigators in the recognition of endoscopic lesions Checking the performance of the central readers Recruitment of patients by investigators - local readers: Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for at least 3 months, with a Crohn's disease activity index < 150 at the time of endoscopy. Each local investigator will have to record 15 videos divided according to his/her overall judgment into 3 status of remission: Complete Remission; Remission almost complete; Remission neither complete nor nearly complete. The colon will be divided into 7 segments: ileum, ileocecal valve, right colon, transverse colon, descending colon, sigmoid colon and rectum. Each segment will be identified by landmarks. Videos will be anonymized and then centralized at a healthcare provider (OVH - SAS). 16 French and Belgian centers will participate in the study leading to a total of 240 films. Analysis of videos by central readers: 12 central readers will independently read 80 out of the 240 videos Videos allocation to central readers will be performed through balanced incomplete block method to ensure that each central reader, as well as each central reader pair, has the same weight in achieving the results. A quantitative evaluation of the depth of endoscopic remission on a visual analogue scale and a qualitative evaluation of the grade of remission on a 5-level ordinal scale will be provided by each central reader, segment by segment and globally, in addition to the description of all lesions identified by segment. Analysis of the data recorded by the central readers: An index (depth of remission) or score (grade of remission) will be constructed from linear or multiple logistic regression models, considering the reader and endoscopy as random factors, to take into account the dependence between the readings performed on different endoscopies by the same central reader or on the same endoscopy by different readers. Variations in readings between central readers will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items. In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested whether the index or score thus constructed is able to predict prolonged clinical remission for 2 years in patients in clinical remission at baseline. If this test is successful, we will have a primary objective and reproducible criterion for evaluating treatments in CD and a useful tool for the management of these patients in clinical practice.

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.

Purpose: There is no previous contrast enhanced ultrasound (CEUS) study for pediatric Crohn disease patients. There are adult studies which included adolescent patients. More pediatric patients have been diagnosed as Crohn disease due to dietary change in Korea and it would be cost effective and clinically useful if CEUS was available in Crohn disease patients as a diagnostic and follow up tool. Objective, hypothesis: Primary Objective To prospectively examine the feasibility of Contrast Enhanced Ultrasound (CEUS) in the assessment of Crohn's disease (CD) using endoscopy as a reference standard Feasibility was defined as the successful examination in over 90% of included patients. Secondary Objective To reaffirm the dosing and safety of ultrasound contrast agent and assess the image quality of the CEUS Methodology: This is a single center prospective observational study. Pediatric patients who was first diagnosed as CD with colonoscopy are enrolled in this study, The disease activity, clinical symptoms are also investigated. Within a period of maximally two weeks from the reference ileocolonoscopy and before any therapeutic changes, the patients underwent CEUS. CEUS was performed by one different pediatric radiologist, masked to all other imaging, endoscopic, and clinical data, except diagnosis of CD. CEUS was analyzed using quantification soft-ware (Vuebox), based on ROI at the most enhanced part of the bowel wall, quantitative parameters were calculated. After the first CEUS, CEUS would be performed after one year. Pediatric population , 20 patients. Imaging procedure: Within a period of maximally two weeks from the reference ileocolonoscopy and before any therapeutic changes, the patients underwent CEUS on the same day. All studies started with a grey scale US examination to find the terminal ileum and assess wall thickness, induration of surrounding fatty tissue and enlarged lymphnodes. Stenosis and length of the pathologic bowel wall was estimated, as well as complications such as abscess formation and fistulae. The thickest segment of the terminal ileum was identified and used to perform analysis of contrast enhancement. The investigators injected the second generation, ultrasonic contrast agent (SonoVue, Bracco, Milan, Italy) as a bolus of 0.03 ml/kg through a three-way 20-gauge catheter in an antecubital vein, followed by a bolus of 5 ml saline solution (0.9% NaCl).CEUS was performed with a 7.5MHz linear probe and contrast-tuned technology, based on allow mechanical index and a real-time scan to ensure the preservation of the contrast agent. A low acoustic power setting was used, expressing a low mechanical index (MI), 0.09-0.14, of a 7.5 MHz linear probe. To assess the vascularization of the involved bowel loop, the contrast uptake over quantitative analysis of the brightness intensity was measured over a period of 40 s, in regions of interest (ROI) located manually in the intestinal wall with at least 2 cm2. The investigators used a dedicated software (Vuebox) and a time-intensity curve was automatically acquired. The quantitative measurement of the contrast uptake was obtained as the difference between the maximum enhancement value and the baseline value before the arrival of contrast. Analysis, evaluation, reporting of results: data acquisition: age, sex, initial treatment, - define involved bowel segment (5 segments: the terminal ileum, right colon (cecum and ascending), transverse colon, left colon (descending and sigmoid) and rectum), Gray scale US parameters identification of the terminal ileum, wall thickness measurement at the maximal diameter of the affected terminal ileum (pathological mural thickening defined as a wall thickness above 3 mm), evaluation of the affected bowel length, stratified wall appearance, perivisceral findings such as creeping fat and stenosis, fistula or abscess CEUS quantitative parameters, Numerous CEUS quantitative perfusion parameters can be derived from this curve. FT indicates fall time; mTTl, mean local transit time; PE, peak enhancement; RT, rise time; TTP, time to peak; WiAUC, wash-in area under the curve; WiR, wash-in rate; WiWoAUC, wash-in 1 wash-out area under the curve; WoAUC, wash-out area under the curve; and WoR, wash-out rate. Clinical and laboratory parameters (CDAI,, CRP, ESR and Calprotectin) interpretation: independent interpretation of CEUS with colonoscopy as gold standard outcome assessment Successfully complete event number without adverse events Treatment response: assessed by pediatric gastroenterologist by lab results, colonoscopy results, and patient symptom improvement

The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.