View clinical trials related to Crohn Disease.
Filter by:The scientific objective of the project is to evaluate if the topical administration of Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the gut in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective is to explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably predict patient response to Adalimumab therapy and hence enable optimized utilization of this treatment option.
Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients. Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a surrogate marker of sympathetic nervous activity, will be similar between the healthy patients and the CD patients; the sympathetic nervous system of the heart will be similar to healthy patients; Crohn's disease patients with normal CRP will have higher drug response compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have higher verapamil response than those with similar symptom profiles who are not infliximab treated.
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was created in Belgium. Over a 2 year period 257 patients are included. These patients will be follow up prospectively during 5 years. Demographic data, family history, disease presentation and disease course including medication are registered in CRF's.
The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Study Hypothesis: It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon. As such, the system may be utilized in CD patients for monitoring mucosal healing. Primary objectives: To evaluate two different video output methods in the visualization of the SB and colon in CD patients Secondary objectives: - Evaluate the level of agreement between PillCam system and ileocolonoscopy on the assessment of CD findings. - Evaluate the effectiveness of PillCam regimen in CD patients Inclusion criteria - Patient is 18 years of age and above - Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by endoscopical, histopathological and/or radiological parameters - Patients' CDAI >150. - Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's disease - Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment - Patient is able and agrees to sign the Informed Consent Form Exclusion criteria - Patient has dysphagia - Patient has congestive heart failure - Patient has renal insufficiency - Patient has cirrhosis - Patient is known or is suspected to suffer from intestinal obstruction - Patient has known previous stricture/obstruction of the SB or colon - Patient has taken NSAID medications less than one month before enrollment - Patient suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers - Chronic use of laxatives - Patient has a cardiac pacemakers or other implanted electro medical devices. - Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception. - Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule. - Patient has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. - Patient has any condition, which precludes compliance with study and/or device instructions. - Patient suffers from life threatening conditions - Patient is currently participating in another clinical study - Patient has known slow gastric emptying time - Patient is allergic or contraindicated to any of the study medications
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.