The effect of body composition on the farmacokinetiek IFX in patients with inflammtoy bowel disease; - FLINX (Farmacokinetics and body composition in IBD patients with IFX)

Zuyderland Medisch Centrum0 个研究点目标入组 33 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Patiënt are eligible to participate in the study if all of the following criteria are met:
•1. Patient, male or female, is aged above 18 years
•2. Patient has an established diagnosis of ulcerative colitis or Crohn*s disease
•3. Patients is being treated with, or start with the treatment IFX for a period of at least 12 weeks, or for the first time during the study period.
•4. Patiënt must be able to understand the patient information and the explanation of the investigator
•5. Patient must be able to undergo the study measurements and understand the instructions of the investigator
•6. Patient is informed about the intention and nature of the study including the possible risks and has signed the informed consent before inclusion.

•Exclusion criteria
•Patients are not eligible if one or more of the following criteria are met:
•1. Patient is mentally or physically not able to participate to the study, including severe mental illness.
•2. Patient has had a change in the dosage of the IFX during the last 5 weeks.
•3. Patients who is currently pregnant, breastfeeding, or is planning to become pregnant during the study period.
•4. Patients suffering from severe comorbidities which can influence the body composition of the pharmacokinetics of IFX;
•a. Current malignancy or a malignancy in the recent history (<5 years), except cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma.
•b. (history of) Liver/renal failure
•c. Short Bowel Syndrome
•d. Heart failure defined as; New York Heart Association (NYHA) Class III or IV
•5. Patients participating in other studies, or participated I another study with an intervention in de last 4 months.

发起方

Zuyderland Medisch Centrum