Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is an idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This current protocol was established in 1996 with the goal of identifying the genetic and environmental components that contribute to the development of IBD, especially in families.

Principal Investigator: Florin Selaru, M.D.
ID: NA_00041583

Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is an idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This protocol is aimed at obtaining tissue samples to test for expression of genes associated with IBD and to better understand the pathogenesis of IBD with the study of genetics, proteomics, physiologic processes and microbiomes (microbiology).

Principal Investigator: Florin Selaru, M.D.
ID: NA_00038329

The purpose of this study is to confirm how well the study drug, Cx601, works at a single dose compared to a placebo (a substance that looks like the study drug but contains no active ingredient) and to see how safe and tolerable the study drug is in patients with fistulizing CD)

This long-term extension (LTE) study is a follow-up of a phase 3 study to evaluate the long-term safety and efficacy of darvadstrocel (Cx601) in the treatment of complex perianal fistula in Crohn’s disease (CD). To be eligible for the LTE study, subjects will have completed the final Week 52 assessment in the Cx601-0303 ADMIRE-CD II study.

Crohn’s Disease (CD) is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhea, abdominal pain, rectal bleeding, weight loss, and fever. Ozanimod is a chemical compound that is thought to act on the immune system by making certain types of white blood cells (lymphocytes including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation. The purpose of this study is to see whether ozanimod is safe and effective for the possible treatment of CD. 

People with moderately to severely active Crohn’s disease may join, who have recently completed research study, RPC01-3201 or RPC01-3202, with blinded ozanimod. Demonstrate the efficacy of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response.

The purpose of this study is to see whether the long-term use of ozanimod is safe and effective for the possible treatment of CD. People with moderately to severely active Crohn’s disease, who have recently participated in research study, RPC01-2201, RPC01-3201, RPC01-3202 or RPC01-3203 with ozanimod or completed a study of ozanimod for CD and meet the criteria for participation in RPC01-3204 (this research study) may join.

The main purpose of this study is to evaluate how safe and tolerable an investigational drug called TAK018 is in subjects with Crohn’s Disease (CD) after bowel resection. The study will also look at whether TAK-018 can stop CD from recurring after surgery.

This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen.

Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data. This will aid in understanding the natural history, risk stratify and optimize therapeutics algorithms for care of patients with ASUC.

The primary purpose of this study is to better understand the pathogenesis, the genetic, microbial, gene expression and serological factors associated with inflammatory bowel disease (IBD) including Crohn’s disease (CD), ulcerative colitis (UC) and indeterminate colitis. This study will also investigate mechanistic pathways in disease pathogenesis. Primary lines will be created to study the mechanisms of the disease. The ultimate goal is to identify markers of disease as well as therapeutic targets to cure IBD or alleviate the symptoms of IBD.

This study is looking at real-time feedback during colonoscopy to determine if it improves the quality of colonoscopy. Endoscopists will conduct colonoscopy procedures with and without instant feedback. The feedback will be provided using the proprietary software "Endoscopic Multimedia Information System" (EMIS). The software is able to derive quality metrics about endoscopist-related factors from streaming video during colonoscopy and immediately inform the endoscopist about the results (i.e. provide real-time feedback).