Effectiveness of Etrasimod on disease activity and patient-reported outcomes in Ulcerative Colitis (EFFECT-UC)

Research summary

This is a multicenter RWE study to evaluate the efficacy of etrasimod daily dose of 2 mg in patients with moderately to severely active UC. The study consists of a 52-Week treatment period, and a 28-day safety follow-up period. This prospective, international, non-interventional primary data collection study will be conducted in countries across the world. Countries will be divided into study regions. A country can be a study region on its own. Each study region will start with patient recruitment as soon as etrasimod is available and can be prescribed in routine clinical practice in at least one of the countries belonging to the study region. The treatment decision is made at the discretion of the physician and patients are treated according to the latest approved local label and local guidelines. Eligible patients will sign the informed consent document (ICD) before they are enrolled in the study. For study regions with multiple countries, recruitment targets will be determined for the study region with the aim of no one country being dominant. As soon as a study region has conducted the last patient visit, data for that study region will be cleaned and the data for that study region will be locked. An interim analysis will be conducted at least once for each study region. The end of the study is defined as the date of the last visit of the last patient in the last participating study region.

Principal Investigator

Dr Alissa Walsh

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

333370