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Crohn Disease clinical trials

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NCT ID: NCT01473927 Completed - Crohn Disease Clinical Trials

Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease

Start date: October 2011
Phase: N/A
Study type: Observational

Background Determining disease activity in IBD is sometimes difficult and, to be accurate, requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker for IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be more reliable and has shown a certain value as predictive marker. Our preliminary data now show, that the serum concentrations of ficolin-2 are significantly higher in CD patients with a HBI >3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like MBL, can activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was not detected in our patient cohort, nor could we find functional deficiencies for ficolin-2 (paper submitted). Study Aims The study is aimed to substantiate the data from our pilot study which shows that ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the study will measure ficolin-2 concentrations in a sufficiently large patient group to obtain enough statistical power and to compare these results with the endoscopic disease score (SES-CD) and CRP and calprotectin values. Statistical analysis of the data will show us if ficolin-2 is a reliable and easy to obtain new marker for active inflammation in CD. Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be collected at the day of endoscopy. Stool sample will be collected within the same week of endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics, ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data will be statistically analyzed.

NCT ID: NCT01470599 Completed - Crohn's Disease Clinical Trials

A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

NCT ID: NCT01468090 Completed - Ulcerative Colitis Clinical Trials

Disease Course in an IBD Cohort in the Era of Biological Treatment

Start date: October 2011
Phase: N/A
Study type: Observational

The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures. Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.

NCT ID: NCT01466374 Completed - Crohn's Disease Clinical Trials

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

NCT ID: NCT01464333 Completed - Crohn's Disease Clinical Trials

Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

Start date: December 16, 2011
Phase:
Study type: Observational

This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.

NCT ID: NCT01453946 Completed - Crohn's Disease Clinical Trials

Safety and Maintenance Study of Entocort for Children With Crohn's Disease

Start date: December 2011
Phase: Phase 3
Study type: Interventional

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

NCT ID: NCT01444092 Completed - Crohn's Disease Clinical Trials

Safety Study of Entocort for Children With Crohn's Disease

Start date: November 2011
Phase: Phase 3
Study type: Interventional

A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

NCT ID: NCT01442025 Completed - Crohn's Disease Clinical Trials

Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

TAILORIX
Start date: June 2012
Phase: Phase 4
Study type: Interventional

To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.

NCT ID: NCT01434693 Completed - Crohn's Disease Clinical Trials

Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.

NCT ID: NCT01428115 Completed - Anxiety Clinical Trials

Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab

RELAX
Start date: December 2011
Phase: N/A
Study type: Observational

It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects. Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders. Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear. The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.