A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.
This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
NCT02367183 — Crohn Disease
Status: Completed
http://inclinicaltrials.com/crohn-disease/NCT02367183/
The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.
NCT02330458 — Crohn's Disease
Status: Active, not recruiting
http://inclinicaltrials.com/crohn-s-disease/NCT02330458/
A Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized to one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.
NCT02249078 — Crohn's Disease
Status: Withdrawn
http://inclinicaltrials.com/crohn-s-disease/NCT02249078/
Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I
Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery. By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases. If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.
NCT02054533 — Ulcerative Colitis
Status: Completed
http://inclinicaltrials.com/ulcerative-colitis/NCT02054533/
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.
NCT01751152 — Inflammation
Status: Completed
http://inclinicaltrials.com/inflammation/NCT01751152/
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
NCT01388933 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01388933/
Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.
NCT01190839 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01190839/
A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However, capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy, MRI and/or CT. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy. Thereafter patients are followed during 12 months to evaluate differences in clinical outcome depending on the randomized result. In combination with the diagnostic validity and inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal diagnostic strategy in these two patient categories.
NCT01019460 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01019460/
Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial
The purpose of this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with Crohn's disease.
NCT00838149 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00838149/
A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease
The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells.
NCT00630643 — Moderate to Severe Crohn's Disease
Status: Completed
http://inclinicaltrials.com/moderate-to-severe-crohn-s-disease/NCT00630643/