Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With I… (NCT03841942) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With IBD in Deep Remission
Stopped: difficulty of inclusion
France64 participantsStarted 2019-06-26
Plain-language summary
Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study
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 18 years
* Patients with a diagnosis of Crohn's disease or ulcerative colitis according to clinical, biological, morphological and endoscopic criteria defined by the ECCO guidelines22, 23
* Patients in deep remission since at least 6 months17:
* CDAI \< 150 for CD, Partial Mayo score \< 3 for UC
* CRP (C reactive protein) \< 10 mg/l
* CDEIS \< 6 (\<3 in each segment) for CD, Mayo endoscopic subscore of 0 or 1 for UC
* For CD patients with small bowel disease: No ulceration on MRI, only asymptomatic fibrotic stenosis without inflammation and retro dilatation. No ulceration on wireless capsule endoscopy if feasible
* For patients with perianal disease: No active draining fistula, or perianal abscess on clinical exam and MRI
* Treatment with infliximab at stable dose (5mg/kg) with a stable interval for at least 4 months
* Infliximab trough level \> 3 ug/ml
* No change in other IBD therapies in the past 4 months
* Signed informed consent form
* Subjects must be able to attend all scheduled visits and to comply with all trial procedures
* Subjects must be covered by public health insurance
Exclusion Criteria:
* Subject unable to read or/and write
* Planned longer stay outside the region that prevents compliance with the visit plan
* Subject who are in a dependency or employment with the sponsor or the investigator
* Participation in another clinical trial or administration of an unapproved drug …
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.