Contract research organization will identify the biomarkers of Tofacitinib therapy in patients with Ulcerative Colitis

Robarts Clinical Trials Inc. is commencing recruitment for the clinical trial of the drug Tofacitinib.

The official title of the study is Pharmacokinetics and pharmacodynamic biomarkers of tofacitinib therapy in patients with ulcerative colitis (PROPHETIC).

This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to tofacitinib therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating tofacitinib therapy according to standard of care.

This is observational study. It began in August 2020 and will continue for the next few years.

Eligible patients will include those who will be prescribed tofacitinib as part of their routine medical care. Tofacitinib induction therapy will be administered according to Standard Of Care (SOC).

This study will involve patients with moderately to severely active Ulcerative Colitis with plans to administer tofacitinib for at least 8 weeks, followed by tofacitinib maintenance therapy for an additional 8 weeks.

18 years of age or older patients who were diagnosed with Ulcerative Colitis for at least 3 months prior to screening can be be entered in the study.

The list of locations:

UCSD (University of California, San Diego), Cedars-Sinai Medical Center and Mayo Clinic, USA

KU Leuven, Campus Gasthuisberg-IBD Studies, Belgium

Mount Sinai Hospital, Canada

Humanitas University, Hamanitas Research Hospital, Italy

Amsterdam Medical Center, IBD Center, Netherlands

IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Spain