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Ulcerative Colitis clinical trials

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NCT ID: NCT06381518 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease

SHUFFLE
Start date: March 12, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks. The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.

NCT ID: NCT05994716 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Telemonitoring for IBD Goodness Examination in Russia

TIGE-Rus
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring, tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD). The main study objective is to evaluate the impact of telemedicine on the quality of life in IBD. The secondary study endpoints are to determine disease activity, the number of IBD relapses, to investigate rate of leukopenia in patients taking azathioprine, to determine medication adherence, psychological well-being and satisfaction with medical care in the telemedicine group in comparison with the face-to-face follow-up group. Moreover, we aim to evaluate association between secondary outcomes and QoL. It is planned to enroll 64 patients. The study duration is 18 months (12 months - patient enrollment, 6 months - telemonitoring). The study consists of 3 stages. The first stage is selection of patients with IBD after treatment in the gastroenterology department. The second stage is face-to-face appointment and general recommendations (for the observation group); monthly completion of questionnaires on the web-platform, possibility to contact with doctor via chat or phone call, access to educational information; a monthly phone call to each patient from to answer any questions or concerns they may have and to interview them according to the checklist (for the intervention group). The third stage is the evaluation of IBD activity (re-hospitalization after 6 months), number of IBD relapses, quality of life, frequency of leukopenia in patients receiving azathioprine therapy, medication adherence, psychological well-being and satisfaction with medical care.

NCT ID: NCT05386290 Enrolling by invitation - Ulcerative Colitis Clinical Trials

A Multicentered Prospective Cohort Study of Chinese IBD Patients

Start date: July 9, 2020
Phase:
Study type: Observational

Inflammatory bowel disease(IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. During the past few decades, the prevalence of IBD is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. Currently, biological medications such as TNFα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in IBD treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-Aminosalicylic Acid, and surgury. However, health-econimic analysis is lacking in Chinese IBD patients and more research is needed for making treatment choice. Meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. The efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. However, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. So a model to predict IBD progression and prognosis concerning pharmacological pathway is going to be explored.

NCT ID: NCT04835506 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

Start date: November 1, 2021
Phase: Phase 4
Study type: Interventional

The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.

NCT ID: NCT04191655 Enrolling by invitation - Ulcerative Colitis Clinical Trials

High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)

Start date: April 3, 2019
Phase: N/A
Study type: Interventional

Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy. This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.

NCT ID: NCT04011943 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Health Improvement (TFM3)

TFM3
Start date: May 21, 2018
Phase: N/A
Study type: Interventional

Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

NCT ID: NCT03640637 Enrolling by invitation - Ulcerative Colitis Clinical Trials

The Role of PET/MRI in the Diagnosis and Treatment of Children and Adolescents With Inflammatory Bowel Diseases

PEDICAD
Start date: October 18, 2018
Phase:
Study type: Observational

The purpose of this study is to test the utility of PET/MRI in diagnosis and management of Inflammatory bowel disease (IBD) in children and adolescents, hereby - To test if PET/MRI scan is an accurate method to diagnose and differentiate Crohn's disease and Ulcerous Colitis in children and adolescents suspected of IBD. - To evaluate whether PET/MRI scan in children and adolescents with Crohn's disease is an accurate method to diagnose relapses and to monitor the effect of biological treatment with monoclonal antibodies directed towards Tumor Necrosis Factor-alpha.

NCT ID: NCT02791854 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Improving the Quality of Care for Adults With Inflammatory Bowel Disease

IBD:QORUS
Start date: February 26, 2016
Phase:
Study type: Observational [Patient Registry]

Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.