TITRATE (inducTIon for acuTe ulceRATivE Colitis) (TITRATE)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 12 February 2022
steroid therapy
intravenous steroids


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.


Previous studies performed in the AMC demonstrated that the patients with acute severe UC receiving IFX are different from patients receiving IFX while in remission.(5) The clearance of IFX is not only determined by demographic parameters (gender, body weight), blood chemistry (CRP, albumin) and anti-drug antibodies, but also disease related variables play an important role. Among others, we have demonstrated that faecal loss of IFX in ASUC patients increases IFX clearance during the induction phase (3). Furthermore, increased expression of TNF-, the target of IFX, influences the clearance of IFX due to target mediated drug disposition (TMDD). Active IBD with high tissue concentrations of TNF- thereby acts as a sink for anti-TNF- antibodies (4). The PK of IFX has been mainly characterized during maintenance therapy. Evaluation of factors that influence the clearance of IFX during induction therapy will allow further optimization an individualization of IFX therapy in ASUC patients.

At present, determination of IFX concentrations in the serum with an enzyme-linked immunosorbent assay (ELISA) is time consuming; physicians often receive the results after as many as 10-20 days. To allow for proactive adjustments in dosing, faster laboratory results are required, preferably in a point-of-care setting. This test is now made available by Bhlmann Laboratories (Switzerland).

The study hypothesis is that in patients with acute severe UC an intensified and personalized IFX dosing regimen using individual PK data from point of care tests as a rapid input to the dashboard system during the induction phase will lead to improved clinical outcomes when compared to standard dosing regimen.

Condition Colitis, Ulcerative
Treatment Infliximab
Clinical Study IdentifierNCT03937609
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on12 February 2022


Yes No Not Sure

Inclusion Criteria

Admission with acute severe UC (defined patients with bloody diarrhoea 6/day and any signs of systemic toxicity (pulse > 90/min, temperature > 37.8C, 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 CRP45) 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
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
Active participation in another interventional trial
Patients with Crohn's disease or IBD-U
Patients with abdominal abscess
Patients with colonic stricture
Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
Active or latent tuberculosis (screening according to national guidelines)
Cardiac failure in NYHA stage III-IV
History of demyelinating disease
Recent live vaccination
Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV
History of cancer in the last 5 years with the exception of non-melanoma skin cancer
A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
Patients unable to attend all study visits
Patients with a history of non-compliance with clinical study protocols
Contraindication for endoscopy
Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
Patients who received cyclosporine in the previous 14 days
Pregnancy and lactation
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