Identify predictors that distinguish between Tofacitinib responders and non-responders based on genotype and cellular and molecular profiles from pinch biopsies blood and stool samples

Brief description of study

The purpose of this study is to identify a set of biomarkers that will predict response to tofacitinib therapy in patients with ulcerative colitis (UC). Biological markers (biomarkers) are substances in the body that can offer signs as to how a drug is affecting the body and a disease. This study will collect clinical data and biological samples (blood, stool, tissue) on subjects who have UC and are currently taking Tofacitinib. Tofacitinib is a pan Janus kinase (JAK) protein inhibitor (JAK1, JAK2, JAK3, and TYK2), that preferentially blocks JAK1 and JAK3.These proteins are inside certain cells (including immune cells) that may stimulate their activity. When immune cells are overactive they can cause symptoms of ulcerative colitis, including diarrhea, rectal bleeding, and abdominal pain. JAK inhibitors such as Tofacitinib are believed to slow down the activity of the immune cells. Tofacitinib was Food and Drug Administration (FDA) approved for rheumatoid arthritis in 2012, and was recently FDA approved (May 2018) for treatment of adults with moderately to severely active UC.


Clinical Study Identifier: s18-00630
Principal Investigator: David P Hudesman.


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