Colitis ulcerosa Crohn's disease Inflammatory Bowel Disease
Conditions
Interventions
None listed
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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: 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the correlation between fat mass, measured by an validated scale, and the IFX level. This will be measured prior to the IFX infusion. The IFX concentration will be measured and analysed in blood. Prior to de IFX infusion the trough level will be measured (according to regular health care). 30 minutes after the end of the infusion the top level will be measured | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondarily, the body composition; measured by skinfold thickness, waist circumference, hand grip strength, BMI and body composition will be correlated to the IFX concentration. Furthermore, de disease activity, inflammation parameters and the amount of adverse effects will be measured en corelated to the fat mass. | — |
Countries
Netherlands
Outcome results
None listed