Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases (MODIFI)
Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- The subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to the initiation of any study procedures.
- The subject is aged 18 to 80 years inclusive.
- The subject has a good understanding of the Dutch language.
- The subject is diagnosed with moderately to severely active ulcerative colitis or Crohn's disease, confirmed by clinical, endoscopic, histological, and/or imaging criteria.
- The subject was in maintenance therapy, later lost their response to treatment and subsequently gained steroid-free, clinical and biological remission following infliximab dose escalation (i.e., by increasing the dose and/or shortening the dosing interval) and had an infliximab trough concentration ≥5 mg/L.
- Adequate contraception in female subjects of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method).
Exclusion Criteria:
- The subject is aged <18 years or >80 years.
- The subject receives infliximab prophylactically (e.g. in the immediate postoperative setting).
- The subject has an ostomy or an ileal anal pouch anastomosis.
- If female subjects, when pregnant (based on a positive serum sample) or lactating or intending to become pregnant or nurse before, during or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period.
- The subject is participating in another interventional clinical trial.
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Interventional arm
Historical control arm
Model-informed precision dosing of infliximab (intravenously administered) using a Bayesian forecasting software tool. Doses and dosing intervals will be derived from the software tool, aiming to maintain adequate exposure (trough concentration target 5 mg/L).
The treating physician adjusted the intravenously administered infliximab doses and dosing intervals without being guided by a model-informed precision dosing software tool. The primary objective was to extend the dosing interval. Therefore, dose de-escalation (interval extension with/without dose adjustment) were performed following a scheme at the treating physician's discretion.