TITRATE (inducTIon for acuTe ulceRATivE Colitis) (TITRATE)

STATUS

Recruiting
End date

Dec 31, 2024
participants needed

120
sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Updated on 12 February 2022

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endoscopy

infliximab

steroid therapy

intravenous steroids

Summary

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.

Description

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.

Details

Condition	Colitis, Ulcerative
Treatment	Infliximab
Clinical Study Identifier	NCT03937609
Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on	12 February 2022

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Eligibility		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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TITRATE (inducTIon for acuTe ulceRATivE Colitis) (TITRATE)