Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn...
Crohn DiseaseTo show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission...
Crohn's DiseaseThe goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
Study Evaluating rhIL-11 in Active Crohn's Disease
Crohn DiseaseInflammatory Bowel DiseaseThe purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from 220-400).
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
Crohn DiseaseSurgeryRetrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.
Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
Crohn's DiseaseThe purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
Food and Crohn's Exacerbation Study (FACES)
Crohn's DiseaseThe proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's...
Crohn's DiseaseThis is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease...
Inflammatory Bowel DiseasesColitis2 moreIBD consists of either ulcerative colitis or Crohn's disease. The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
Crohn DiseaseUlcerative ColitisThis is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL >7μg/mL: interval prolongation allowed; (C) TL <3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL <3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target * Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients. The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.
Johns Hopkins Crohn's Disease and Ulcerative Colitis Study
Inflammatory Bowel DiseaseInflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This current protocol was established in 1996 with the goal of identifying the genetic and environmental components that contribute to the development of IBD, especially in families.