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Colitis clinical trials

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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: NCT02170714 Completed - Clinical trials for Pediatric Acute Severe Colitis

Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis

Start date: May 2010
Phase: N/A
Study type: Observational

Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a second line therapy. This study was performed in consecutively observed pediatric patients with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)- European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN) guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical predictors of poor outcome. Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All patients were treated according to the above mentioned guidelines for ASC and received intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy rate and the efficacy of IFX in avoiding colectomy were evaluated.

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: 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

NCT ID: NCT02144350 Terminated - Ulcerative Colitis Clinical Trials

Hyperbaric Oxygen for Ulcerative Colitis

Start date: August 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.

NCT ID: NCT02144129 Withdrawn - Ulcerative Colitis Clinical Trials

Effects of WB-EMS in Ulcerative Colitis Patients

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

The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis. Our main hypothesis is that active WB-EMS application is significantly more favorable to address our primary endpoints compared with passive application. Our secondary hypothesis is that passive WB-EMS application is significantly more favorable to address our primary endpoints compared with non-training control.

NCT ID: NCT02142725 Terminated - Ulcerative Colitis Clinical Trials

Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

PROTECT-1
Start date: July 21, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.