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Colitis, Ulcerative clinical trials

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NCT ID: NCT03705117 Completed - Ulcerative Colitis Clinical Trials

Open-label V565 Target Engagement Study

Start date: May 23, 2017
Phase: Phase 1
Study type: Interventional

The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

NCT ID: NCT03698812 Recruiting - Clinical trials for Ulcerative Colitis in Remission

A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis

Start date: January 1, 2017
Phase:
Study type: Observational

Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.

NCT ID: NCT03698500 Recruiting - Ulcerative Colitis Clinical Trials

Specific microRNAs as Potential Biomarker for Inflammatory Bowel Disease

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

The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn`s disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Furthermore, the accuracy of miRNA-320a to distinguish CD or UC from irritable bowel syndrome (IBS) should be evaluated . The study is designed as a single center non-randomised prospective trial.

NCT ID: NCT03695185 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.

NCT ID: NCT03689673 Completed - Ulcerative Colitis Clinical Trials

Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)

Start date: April 24, 2013
Phase:
Study type: Observational

The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.

NCT ID: NCT03679546 Recruiting - Ulcerative Colitis Clinical Trials

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

EFFICACI
Start date: January 4, 2019
Phase: Phase 4
Study type: Interventional

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades. However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up. Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue. Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).

NCT ID: NCT03675477 Completed - Ulcerative Colitis Clinical Trials

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

Start date: April 13, 2019
Phase: Phase 2
Study type: Interventional

The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.

NCT ID: NCT03671980 Completed - Ulcerative Colitis Clinical Trials

IBD Self-management Website and Home Faecal Calprotectin Monitoring

Start date: April 4, 2017
Phase: N/A
Study type: Interventional

6 month exploratory feasibility study to assess if a combination of MyMedicalRecord supported self-management website and a home faecal calprotectin smartphone testing kit is a feasible and acceptable means for patients to monitor for signs of relapse after treatment de-escalation.

NCT ID: NCT03669822 Recruiting - Ulcerative Colitis Clinical Trials

Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC)

MASCC
Start date: November 10, 2018
Phase:
Study type: Observational

Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data.

NCT ID: NCT03669029 Not yet recruiting - Colitis, Ulcerative Clinical Trials

Optimization of Golimumab Treatment in Ulcerative Colitis

Start date: October 1, 2018
Phase: Phase 4
Study type: Interventional

This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.