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Colitis clinical trials

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NCT ID: NCT03196427 Active, not recruiting - Ulcerative Colitis Clinical Trials

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: July 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

NCT ID: NCT03172195 Active, not recruiting - Colitis, Ulcerative Clinical Trials

Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up

VIRCH
Start date: October 11, 2017
Phase: N/A
Study type: Interventional

Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).

NCT ID: NCT03011268 Active, not recruiting - Colitis,Ulcerative Clinical Trials

Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?

BIOSTOP
Start date: June 9, 2017
Phase: N/A
Study type: Interventional

The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse

NCT ID: NCT03006068 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

U-ACHIEVE
Start date: January 31, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

NCT ID: NCT03000101 Active, not recruiting - Ulcerative Colitis Clinical Trials

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

POME2016
Start date: January 19, 2017
Phase: N/A
Study type: Interventional

The aim of this research is to study the effects of a pomegranate juice on calprotectin levels in patients suffering of inflammatory bowel disease (IBD) in clinical remission. Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical and molecular inflammatory response markers will be also assessed.

NCT ID: NCT02922374 Active, not recruiting - Clinical trials for Acute Severe Colitis (ASC)

Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.

NCT ID: NCT02914717 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Belgian SMART Study Evaluating the Use of Golimumab for Ulcerative Colitis

BE SMART
Start date: September 2016
Phase: N/A
Study type: Observational

Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and abdominal pain. Both infliximab and adalimumab have been used with success for moderate-to-severe UC refractory to conventional therapy. More recently, golimumab, another anti-TNF antibody, has been added to the treatment armamentarium. In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50 mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through week 54 significantly more often than patients randomized to placebo. Data on the use of golimumab in daily clinical practice are unavailable. The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will be steroid-free golimumab continuation at week 26. Secondary endpoints will include (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal healing, (steroid-free) complete mucosal healing hospitalization-free survival, and colectomy-free survival.

NCT ID: NCT02914535 Active, not recruiting - Ulcerative Colitis Clinical Trials

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

SELECTIONLTE
Start date: February 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).

NCT ID: NCT02808780 Active, not recruiting - Ulcerative Colitis Clinical Trials

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

OPAL
Start date: December 16, 2016
Phase:
Study type: Observational

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.

NCT ID: NCT02721719 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Role of CD4+ T Cell Subsets in the Mechanism of Action of Vedolizumab in Ulcerative Colitis

Start date: May 2016
Phase:
Study type: Observational

The cause of Inflammatory Bowl Disease (IBD) is not known, but studies from patients with IBD have found that these patients make unusually strong immune responses to their own intestinal tissues and to bacteria that normally live in the healthy gut. These overactive immune responses might result from an imbalance of T-lymphocytes, which are a type of white blood cell that recognize and respond to threats like infection or damaged tissues. In healthy tissues, a type of T-lymphocytes called T-regulatory cells control excess inflammation by preventing other T cells, called T-effector cells from responding. We believe that T-regulatory cells are somehow less active in IBD, resulting in damage to intestinal tissues by the T-effector cells. T-lymphocytes, including both T-regulatory and T-effector cells, are guided to different parts of the body by 'alpha4beta7-integrin' molecules. Vedolizumab or Entyvio works by blocking this homing molecule so that T cells do not reach the intestine, but stay in the blood where they cannot aggravate your IBD. This study will help in understanding how Vedolizumab helps to heal or decrease the symptoms of your Ulcerative Colitis. The effect of Vedolizumab on different types of T cells in the human intestine has not yet been studied. However, the investigators think that Vedolizumab will shift the balance of T cells in the intestine towards more healing T-regulatory cells and less damaging T-effector cells. The purpose of this study is to measure the different types of T cells in participants' blood and intestinal tissue before and during Vedolizumab treatment.