MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease
ConditionIBD (Inflammatory Bowel Disease)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorMeyer Children's Hospital IRCCS
About this trial
This is a monocentric, non-profit prospective cohort study with longitudinal biological sampling. The study will include patients with IBD starting biological therapy with infliximab. During four routine clinical visits in the induction phase (standard or accelerated) and the first maintenance visit, two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected. Plasma samples will be obtained from leftover blood collected during routine clinical practice, with no additional blood draws required. The induction regimen (standard or accelerated) will be determined by the treating physicians based on the patient's clinical and laboratory characteristics and will not be influenced by study participation. The study focuses on the first four infliximab infusions (three induction and one maintenance). Standard induction lasts 14 weeks (infusions at weeks 0, 2, 6, and 14), while accelerated induction lasts 8 weeks (infusions at weeks 0, 1, 4, and 8).
The primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 3 and 18 years
diagnosis of Crohn's disease or ulcerative colitis
starting biological therapy with infliximab;
Signed informed consent.
Disqualifiers
Patients in whom the diagnosis of IBD has not been confirmed according to standardized endoscopic and histological criteria;
Patients who refuse to participate in the study.
Trial design
Design model
Single group
Treatments tested in this trial
Infliximab level analysis in biological samples
Diagnostic testFor both patients receiving induction according to the standard of care and those receiving induction with an optimized regimen, Infliximab levels will be measured in saliva before and after infusion and in a plasma sample collected prior to drug infusion
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Paediatric Patients with Inflammatory Bowel DiseaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of Infliximab levels between saliva and plasma samples
The primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels measured in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov