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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03937609
Recruitment Status Recruiting
First Posted May 6, 2019
Last update posted February 6, 2020
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-α, the target of IFX, influences the clearance of IFX due to target mediated drug disposition (TMDD). Active IBD with high tissue concentrations of TNF-α thereby acts as a sink for anti-TNF-α 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 Bühlmann 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.
|Experimental: Intervention group
All eligible patients will receive an intravenous infusion of IFX at 5 mg/kg IFX at week 0. The intervention group will receive model based dosing of infliximab with 5mg/kg at various timepoints based on the dashboard model.
infliximab iv 5mg/kg
|Other: Standard dosing
All eligible patients will receive an intravenous infusion of IFX at 5 mg/kg IFX at week 0. The control group will continue with 5 mg/kg IFX at week 2 and 6, followed by every 8 weeks.
infliximab iv 5mg/kg
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. 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 30 mm/h, or C-reactive protein [CRP] > 30
2. 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
3. Patients going through baseline endoscopy and biopsy sampling (including CMV) before
starting on IFX treatment
4. In the opinion of the investigator, the subject is capable of understanding and
complying with protocol requirements.
5. The subject signs and dates a written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.
6. 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]).
1. Patients at imminent need of surgery as judged by the treating clinician
2. Previous use of IFX
3. Enteric pathogens (such as Salmonella, Shigella, Yershinia, Campylobacter and C.
difficile) detected by stool analysis within 2 weeks prior to enrollment or at
4. Active participation in another interventional trial
5. Patients with Crohn's disease or IBD-U
6. Patients with abdominal abscess
7. Patients with colonic stricture
8. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma,
which has been removed
9. Active or latent tuberculosis (screening according to national guidelines)
10. Cardiac failure in NYHA stage III-IV
11. History of demyelinating disease
12. Recent live vaccination
13. 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
14. History of cancer in the last 5 years with the exception of non-melanoma skin cancer
15. A history of alcohol or illicit drug use that in the opinion of the principal
investigator (PI) would interfere with study procedures
16. Patients with psychiatric problems that in the opinion of the PI would interfere with
17. Patients unable to attend all study visits
18. Patients with a history of non-compliance with clinical study protocols
19. Contraindication for endoscopy
20. Patients who received any investigational drug in the past 30 days or 5 half-lives,
whichever is longer
21. Patients who received cyclosporine in the previous 14 days
22. Pregnancy and lactation
Contact: Geert DHaens, PI 0031205663534 firstname.lastname@example.org
Contact: Esmé Clasquin 0031205661125 email@example.com
Academic Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Geert DHaens Amsterdamumc location AMC