Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
Participant gender:
Summary
It is planned to enroll 80 UC patients who will require optimization of golimumab after
secondary LOR. The review of the study protocol and its approval by an Independent Ethics
Committee of the University of Saint Etienne are pending. All patients enrolled will give
their written informed consent before being included. This study will be conducted in
accordance with the ethical principles that have their origins in the Declaration of
Helsinki, in compliance with the approved protocol, good clinical practice and applicable
regulatory requirements. Patients will visit the investigator from screening visit to visit 6
at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation,
patients will record clinical parameters required to calculate the partial Mayo score
reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8
(optional) and at the end of the follow-up to calculate total Mayo score.