Golimumab dose Optimisation to Adequate Levels to Achieve Response in Colitis
GOAL-ARC was a nationwide multi-centred investigator initiated randomised control trial to evaluate the use of personalised Golimumab (GLM) dose adjustment in ulcerative colitis. The primary objective was to ascertain if dose adjustment of GLM, based on GLM drug levels and FCP levels, results in higher response and remission rates than standard SmPC dosing.
Treatment related Outcomes Associated with SToma in IBD
The overall aim is to achieve consensus on which clinical and patient reported outcomes are most representative of clinical effectiveness in patients with IBD with stomas receiving treatment/intervention.
Use of Air Displacement Plethysmography to Measure Body Composition to Assess Associations in Disease Activity for IBD
This is a pilot study with an aim of recruiting 30 patients and 15 healthy controls over a period of 12 months with 6 months of prospective follow-up and 24 months of retrospective analysis. After initial analysis, a more specific sample size can be calculated for validation.
IBD CAncer and seRious infections in Europe
I-CARE is the first observational European prospective cohort study that will provide unique information (safety, efficacy, risk-benefit ratio, and healthcare costs) on long-term use of recommended therapy in IBD, using a predefined standardised follow-up. These real world date will be used to guide clinicians as well as Healthcare authorities to provide the best care for IBD patients by optimising avalaible therapies.
Stelara Treatment Effectiveness in Irish Gastroenterology
STEIG is a retrospective study of clinical outcomes of off licence treatment with Ustekinumab for Crohn's Disease. We aimed to evaluate the real-world effectiveness of subcutaneous USK in medium-to-long term CD treatment outcomes.
Healing of Antibiotic Refractory Pouchitis with Xeljanz
HARP-X was a prospective multi-centre, open label induction and randomised maintenance pilot study of Tofacitinib in subject with chronic, antibiotic refractory or dependent pouchitis. The primary objective is to determine the effect of tofacitinib maintenance therapy on endoscopic response in subjects with active, chronic, antibiotic dependent or refractory pouchitis.
Reduced serological response to COVID-19 vaccines in patients with IBD is further diminished by TNF inhibitor therapy
VARIATION was a prospective, multi-centre Irish study aiming to determine the impact of IBD and various medications for treatment of IBD on antibody responses to vaccination against COVID-19.
Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease
SECURE-IBD is an international, pediatric and adult database to monitor and report on outcomes of COVID-19 occurring in IBD patients. With the collaboration of our entire IBD community, we will rapidly be able to define the impact of COVID-19 on patients with IBD and how factors such as age, comorbidities, and IBD treatments impact COVID outcomes. This database was active from March 2020 to January 2022.
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