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Colitis, Ulcerative clinical trials

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NCT ID: NCT01984047 Completed - Colitis, Ulcerative Clinical Trials

Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002

Start date: January 10, 2014
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a screening visit and if eligible and consenting, will attend to participate in the study within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing when each subject will receive a single intravenous dose of GSK3050002 or placebo, then remain in house under supervision until discharged on Day 3. Subjects will then return for 7 outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be 7-14 days following the last visit.

NCT ID: NCT01971814 Completed - Clinical trials for Inflammatory Bowel Disease

Early Serum Infliximab Levels in Severe Ulcerative Colitis.

EaSiFx
Start date: November 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.

NCT ID: NCT01966744 Completed - Ulcerative Colitis Clinical Trials

Self-Management Assistance for Recommended Treatment (SMART) Portal

SMART
Start date: July 2013
Phase: N/A
Study type: Observational

The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.

NCT ID: NCT01960439 Completed - Ulcerative Colitis Clinical Trials

Responsiveness of Endoscopic Evaluation in UC

Start date: July 2013
Phase: N/A
Study type: Observational

The purpose of this study of this study is to assess the responsiveness and validity of CIMS (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis) clinical disease activity by measuring: The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in UC.

NCT ID: NCT01959282 Completed - Colitis, Ulcerative Clinical Trials

A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: November 15, 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT01959165 Completed - Ulcerative Colitis Clinical Trials

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Start date: November 21, 2013
Phase: Phase 2
Study type: Interventional

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

NCT ID: NCT01947816 Completed - Ulcerative Colitis Clinical Trials

Special Investigation in Patients With Ulcerative Colitis

Start date: August 9, 2013
Phase:
Study type: Observational

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis. 1. Unknown adverse reactions (in particular, clinically significant) 2. Incidence and conditions of occurrence of adverse reactions in clinical practice 3. Factors likely to affect the safety and effectiveness

NCT ID: NCT01947101 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children

FMT
Start date: February 2014
Phase: Phase 1
Study type: Interventional

Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an important role in the development of UC. There are many treatment options for UC such as steroids,and other medications that decrease inflammation. However, none of these can cure the disease. This study aims to treat pediatric UC in an alternative fashion by changing the microbes in the gut by giving the participant's stool specimens from healthy adult individuals. There is some evidence from a few cases of adult UC that this therapy may cure the disease or at least provide long lasting suppression (remission) of the symptoms. The investigators would like to test this therapeutic intervention in children with UC. The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3) The investigators will also study the effects of the treatment on colonic gene expression.

NCT ID: NCT01941589 Completed - Ulcerative Colitis Clinical Trials

Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

NCT ID: NCT01931644 Completed - Breast Cancer Clinical Trials

At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

Start date: July 2013
Phase:
Study type: Observational

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