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Colitis, Ulcerative clinical trials

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NCT ID: NCT02846961 Completed - Ulcerative Colitis Clinical Trials

Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease

OACIS
Start date: July 2016
Phase:
Study type: Observational

The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.

NCT ID: NCT02840721 Completed - Colitis, Ulcerative Clinical Trials

Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.

Start date: October 26, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.

NCT ID: NCT02825914 Completed - Clinical trials for Inflammatory Bowel Diseases

CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

CAGLUCIM
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.

NCT ID: NCT02822352 Completed - Ulcerative Colitis Clinical Trials

RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis

VIRTUOSO
Start date: August 2016
Phase: N/A
Study type: Interventional

Colitis is inflammation of the large bowel and it is often caused by conditions known as ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated inflammatory response against the bowel - the body attacks the bowel. Patients who have had colitis affecting most of the large bowel for more than 8 years are at increased risk of cancer of the large bowel. In view of this, many national gastroenterology organisations have recommended that such patients have regular colonoscopies to detect pre-cancerous areas and even early cancer in the large bowel. Early detection of such areas, will lead to early treatment thereby reducing the risk of developing significant large bowel cancer. These regular colonoscopies are known as surveillance colonoscopies. Official international guidelines for surveillance in patients with ulcerative and Crohn's colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters and of any suspicious areas. Recent studies have shown that spraying dye such as indigo carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous cells. This technique is time-consuming, and tedious. There are no set standards of what is considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an alternative method to improve the detection of pre-cancerous tissue in patients with longstanding colitis.

NCT ID: NCT02819635 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: September 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

NCT ID: NCT02818686 Completed - Clinical trials for Ulcerative Colitis, Active Moderate

TD-1473 for Active Ulcerative Colitis (UC)

Start date: October 3, 2016
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

NCT ID: NCT02818543 Completed - Ulcerative Colitis Clinical Trials

Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis

Start date: March 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.

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: NCT02808390 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

SEGMENT
Start date: November 28, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

NCT ID: NCT02801240 Completed - Crohn's Disease Clinical Trials

Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized, open-label study will assess the effect of a nutrition support product on nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be enrolled in the study and asked to take the product for 12 weeks. The primary measures of the study are several blood markers of nutritional status.