Golimumab Trough Levels in Patients With Ulcerative Colitis (NCT03773445) | Clinical Trial Compass
CompletedNot Applicable
Golimumab Trough Levels in Patients With Ulcerative Colitis
Spain52 participantsStarted 2019-03-01
Plain-language summary
Proactive therapeutic drug monitoring of Anti-TNFs with drug titration to a therapeutic window is associated with favorable long-term therapeutic outcomes in IBD and may be superior to reactive therapeutic drug monitoring. Moreover, many exposure-response relationship studies have shown that higher serum anti-TNF drug concentrations are associated with better clinical outcomes in IBD, suggesting that it is maybe time to go from a 'treat-to-target' to a 'treat-to trough' therapeutic approach. In this scenario, there are very limited data regarding therapeutic drug monitoring with golimumab in UC and even no data regarding a therapeutic window to target for important objectives outcomes like mucosal healing and histological remission.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than or equal to 18 years.
* Patients with a diagnosis of ulcerative colitis at least 12 months prior to the start of the study.
* Patients previously treated with golimumab for ulcerative colitis prescribed according to the usual clinical practice of each center and who have received at least 5 maintenance doses according to the guidelines accepted in the technical file.
* Sign of informed consent.
Exclusion Criteria:
* Patients with Crohn's disease or colitis pending classification
* Alterations in the coagulation that contraindicate the taking of biopsies
* Patients with moderate-severe heart failure (grades III / IV NYHA)
* Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections
* Psychiatric illness that discourages participation in the study
* Patients with a history of hypersensitivity to golimumab, to other murine proteins or to any of the excipients included in the golimumab data sheet
* Withdrawal of the informed consent by the patient
* Any other condition that in the opinion of the investigator discourages the participation of the subject in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between Golimumab trough levels and Endoscopic remission
Timeframe: Cross-Sectional: 15 days before or after the extraction of levels
2
Correlation between Golimumab trough levels and Endoscopic healing
Timeframe: Cross-Sectional: 15 days before or after the extraction of levels
3
Correlation between Golimumab trough levels and Histological remission
Timeframe: Cross-Sectional: 15 days before or after the extraction of levels