The aim of this study is to investigate whether intensive, personalized IFX dosing by using a pharmacokinetics driven dashboard system during the induction phase in patients with acute severe UC leads to increased treatment success (as defined by clinical and endoscopic response at week 6) as compared to the standard dosing.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Admission with acute severe UC (defined patients with bloody diarrhoea ≥ 6/day and any signs of systemic toxicity (pulse \> 90/min, temperature \> 37.8°C, haemoglobin \< 105 g/l, erythrocyte sedimentation rate \[ESR\] \> 30 mm/h, or C-reactive protein \[CRP\] \> 30 mg/l)
✓. Failure to intravenous steroid treatment as defined by the Oxford criteria (more than 8 stools/d or 3-8 stools/d and CRP≥45) and a Lichtiger score ≥ 10 on day 3 after starting iv steroid treatment
✓. Patients going through baseline endoscopy and biopsy sampling (including CMV) before starting on IFX treatment
✓. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
✓. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout week 26. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]).
Exclusion criteria
✕. Patients at imminent need of surgery as judged by the treating clinician
✕. Previous use of IFX
✕. Enteric pathogens (such as Salmonella, Shigella, Yershinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
What they're measuring
1
Increased treatment success
Timeframe: week 6
Trial details
NCT IDNCT03937609
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)