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Crohn's Disease clinical trials

View clinical trials related to Crohn's Disease.

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NCT ID: NCT02048618 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

Start date: February 2014
Phase: Phase 2
Study type: Interventional

- 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment. - During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

NCT ID: NCT02039063 Completed - Crohn's Disease Clinical Trials

A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease

Start date: April 5, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will receive repeated intravenous administration of E6011.

NCT ID: NCT02038920 Completed - Crohn's Disease Clinical Trials

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

Start date: January 28, 2014
Phase: Phase 3
Study type: Interventional

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

NCT ID: NCT02019602 Completed - Clinical trials for Rheumatoid Arthritis

A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta

CRIB
Start date: January 2014
Phase: Phase 1
Study type: Interventional

The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.

NCT ID: NCT02015793 Completed - Crohn's Disease Clinical Trials

Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

NCT ID: NCT02010762 Completed - Crohn's Disease Clinical Trials

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease

DETECT
Start date: February 2013
Phase: Phase 4
Study type: Interventional

The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear promising but are hampered by immunogenicity, side effects and high cost. Vitamin D has recently received a lot of scientific attention and was found to have strong anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally missed its endpoint because of lack of power. The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in the prevention of postoperative recurrence.

NCT ID: NCT01991314 Completed - Ulcerative Colitis Clinical Trials

Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy. IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity. To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.

NCT ID: NCT01988506 Completed - Clinical trials for Rheumatoid Arthritis

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

TRANSREG
Start date: January 6, 2014
Phase: Phase 2
Study type: Interventional

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

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: NCT01959087 Completed - Crohn's Disease Clinical Trials

Single Port Colic Laparoscopic Surgery

TRUE
Start date: January 27, 2014
Phase: N/A
Study type: Interventional

This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.