Inflammatory bowel diseases - Crohn's disease - ulcerative colitis
Conditions
Interventions
Trade Name: Inflectra
Product Name: infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg mill
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is aged 18 to 80 years inclusive. - 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - The subject is aged 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the steroid-free, combined clinical and biological outcome between model-informed infliximab dose de-escalation and standard dose de-escalation in patients with inflammatory bowel diseases. ;Secondary Objective: -To compare the (evolution of) infliximab exposure -To compare the (evolution of) clinical outcome -To compare the (evolution of) biological outcome -To compare the socio-economic aspects -To compare the quality of life between model-informed infliximab dose de-escalation and standard dose de-escalation in patients with inflammatory bowel diseases. ;Primary end point(s): The proportion of patients maintaining steroid-free, combined clinical and biological remission during one year after infliximab dose de-escalation.;Timepoint(s) of evaluation of this end point: Continuously during one year after the first infliximab infusion in the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of patients maintaining (steroid-free), combined clinical and biological remission at - The proportion of patients maintaining (steroid-free) clinical remission at - The proportion of patients maintaining (steroid-free) clinical remission during - The proportion of patients maintaining (steroid-free) biological remission at - The infliximab trough concentration at - The average infliximab trough concentration during - The probability of target attainment for the trough concentration target attainment at - The probability of target attainment for the trough concentration target attainment during - The model-predicted area under the infliximab concentration-time curve during - The infliximab dose at - The total infliximab dose during - The number of infliximab infusion visits during - The direct cost of infliximab therapy at - The direct cost to proportion of patients maintaining steroid-free, combined clinical and biological remission ratio at one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm. - The total cost (i.e., direct and indirect costs) of infliximab therapy - The quality-adjusted life years - The total cost to quality-adjusted life year ratio before versus after one year dose de-escalation within each patient in the prospective (model-informed dose de-escalation) study arm. ;Timepoint(s) of evaluation of this end point: Continuously during one year after the first infliximab infusion in the trial ("during") or at one year after the first infliximab infusion in the trial ("at"). | — |
Countries
Belgium
Contacts
Public ContactDienst maag-, darm-, leverziekten
UZ Leuven, Campus Gasthuisberg
Outcome results
None listed