Gastroenterology
The Gastroenterology Department at St. James’s Hospital has long established clinical and translational research programmes conducting a broad range of investigator-led and industry-sponsored studies in variety of subspecialty areas of GI disease. The department has a particular focus on studies in inflammatory bowel disease including ulcerative colitis and Crohn’s disease. The group also has a strong interest in and an active clinical trial portfolio in the area of gastrointestinal neuroendocrine tumours.
Study Name | Study Title | Study type | Sponsor | Sponsor Type |
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GOAL-ARC | Golimumab dose Optimisation to adequate levels to achieve response in Colitis | Clinical trial (NCT02687724) (2015-004724-62) | UCD | Academic |
Abbvie UC | A Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Clinical Trial (NCT02819635) (2016-000641-31) | AbbVie | Industry |
Abbvie OLE M14-533 | A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) | Clinical Trial (NCT03006068) (2016-000674-38) | AbbVie | Industry |
DIVERSITY | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Clinical trial (NCT02914600)(2016-001367-36) | Gilead Sciences | Industry |
DIVERSITY OLE | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Clinical trial (NCT02914561)(2016-002763-34) | Gilead Sciences | Industry |
Sublimity CYC-202 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Clinical Trial | Sublimity Therapeutics | Industry |
N/A | Pharmacogenomic markers of biologic therapy outcome in Inflammatory Bowel Disease | Observational study | INITIative | Academic |
N/A | Human colonic tissue ex-plants explants as precision medicine tools in Inflammatory Bowel Disease | Observational study | N/A | Academic |
GMI-IBD | The Genomic Basis of Inflammatory Bowel Disease (IBD) in Ireland – St. James Hospital | Observational study with blood tests | Genuity Science | Commercial: Industry |
Study Name | Study Title | Study Type | Sponsor | Sponsor Type |
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Clarinet Forte | Efficacy and safety of lanreotide autogel 120mg administered every 14 days in well differentiated metastatic or locally advanced unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide autogel 120mg administered every 28 days | Clinical trial | IPSEN | Industry |
GEM Project | A multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease | Observational-non invasive | N/A | Academic |
Pouchitis | A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis | Clinical trial | Atlantic Pharmaceuticals | Industry |
MOBIDIC | Molecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC)Detection study In Crohn's disease patients (MOBIDIC) Version Modification | Observational with radiology or blood tests | French Research Consortium | Industry |
N/A | Biomarkers and Drug Pharmacokinetic Factors Associated with Vedolizumab Therapy Outcome in Inflammatory Bowel Disease | Prospective observational study | N/A | Academic |
REMINET | A European, multicentre, Phase II/III randomised Double-Blind, Placebo controlled study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment | Clinical trial | French Research Consortium | Academic |