View clinical trials related to Colitis, Ulcerative.
Filter by:The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.
Objectives: To examine the effect of accelerated infliximab induction in children with moderate to severe UC. Design: A multi-center, prospective, randomized, open label study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years (Overall, 84 patients) with moderate to severe UC who are corticosteroid dependent/resistant thus planned to receive infliximab induction. Intervention: Group 1 (intervention) will receive an accelerated induction at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15. Group 2 (standard) will receive a per protocol induction at 0,2,6 weeks (5 mg/kg) and then at week 14. Drug levels will be obtained prior to each infusion in each group (up to week 20). Further maintenance will be planned according to drug levels at weeks 15 and 14, respectively. Follow-up will continue without further interventions till 52 weeks following induction. Main outcome measure: Clinical remission, on infliximab at week 20. Secondary outcome measures: 1. Colectomy free rates at week 20 and 52. 2. Clinical remission on infliximab at week 52. 3. Drug levels and anti-drug antibodies prior to last study infusion. 4. Anthropometric and laboratory measures including calprotectin at the end of induction, week 20 and week 52 5. Changes in fecal microbiome, virome and bile acids content. Sample size: In order to demonstrate 30% difference in clinical remission rate between groups is significant, we will need to study 36 children in each group to be able to reject the null hypothesis that the failure rates between the groups are equal with probability (power) of 80% and a type I error probability of 0.05.
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.
UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties. The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).
The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and its effect on long and short-term outcomes including colectomy rate. Secondary aim of this study is to assess the safety of tacrolimus as an induction agent in patients with UC.
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine. This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.
The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.