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Colitis, Ulcerative clinical trials

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NCT ID: NCT02200445 Completed - Ulcerative Colitis Clinical Trials

Low Dose IL-2 for Ulcerative Colitis

Start date: February 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.

NCT ID: NCT02197780 Completed - Ulcerative Colitis Clinical Trials

Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD

CACATU
Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

RATIONALE: A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical decision rule that included a calprotectin stool test to discern which patients require further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of missing IBD cases. Although the number of negative endoscopies was reduced after introduction of this strategy, still 22% of the referred children and teenagers underwent an unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils and this stool marker may be more IBD-specific than calprotectin. OBJECTIVE: To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity HYPOTHESIS: Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.

NCT ID: NCT02179372 Completed - Ulcerative Colitis Clinical Trials

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.

NCT ID: NCT02171429 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS II
Start date: November 14, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naIve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28948; NCT02163759) was independently conducted.

NCT ID: NCT02165215 Completed - Colitis, Ulcerative Clinical Trials

A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

LAUREL
Start date: August 12, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

NCT ID: NCT02163759 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS I
Start date: November 4, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

NCT ID: NCT02161640 Completed - Ulcerative Colitis Clinical Trials

Vascular Dysfunction in Paediatric IBD

Start date: September 2014
Phase: N/A
Study type: Observational

Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory conditions acquired due to genetic susceptibility and/or environmental triggers. The disease manifestations are being increasingly seen in young children and the life-long debilitation has a severe effect on quality of life. Limited evidence suggests, although rare, in some young IBD individuals vascular complications may ensue. This leads to increased risk of vascular problems such as thrombosis, arterial disease and stroke. In the present project we aim to study and highlight potential vascular changes in young Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender matched controls. Vasculature will be measured in multiple ways including blood analysis in the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of vascular dysfunction as this will open new avenues for early therapeutic intervention.

NCT ID: NCT02155335 Completed - Ulcerative Colitis Clinical Trials

Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

SMART
Start date: July 1, 2014
Phase: Phase 4
Study type: Interventional

This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

NCT ID: NCT02149043 Completed - Ulcerative Colitis Clinical Trials

Thermography in Surveillance of Ulcerative Colitis

Thermo
Start date: January 2015
Phase:
Study type: Observational

Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

NCT ID: NCT02148640 Completed - Clinical trials for Rheumatoid Arthritis

The NOR-SWITCH Study

NOR-SWITCH
Start date: October 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis