The effect of body composition on the farmacokinetiek IFX in patients with inflammtoy bowel disease;

Suspended

• Conditions: Colitis ulcerosa; Crohn's disease; Inflammatory Bowel Disease; 10017969

• Registration Number: NL-OMON46317
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the correlation between fat mass, measured by an<br /><br>validated scale, and the IFX level. This will be measured prior to the IFX<br /><br>infusion. The IFX concentration will be measured and analysed in blood. Prior<br /><br>to de IFX infusion the trough level will be measured (according to regular<br /><br>health care). 30 minutes after the end of the infusion the top level will be<br /><br>measured </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondarily, the body composition; measured by skinfold thickness, waist<br /><br>circumference, hand grip strength, BMI and body composition will be correlated<br /><br>to the IFX concentration.<br /><br><br /><br>Furthermore, de disease activity, inflammation parameters and the amount of<br /><br>adverse effects will be measured en corelated to the fat mass. </p><br>