Integrated pharmacokinetics of infliximab, adalimumab and golimumab in serum, tissue and faeces of patients with moderate to severe Ulcerative Colitis and Crohn's Colitis

Completed

• Conditions: inflammatory bowel disease; ulcerative colitis/Crohn's colitis; 10017969

• Registration Number: NL-OMON47648
• Lead Sponsor: Maag-, darm-, leverziekten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients aged * 18 years, either male or female, moderate to severe Ulcerative
Colitis or Crohns* colitis (respectively according to Mayo score (2 or 3) or
SES-CD (*7) at baseline endoscopy), starting on Infliximab, adalimumab or
golimumab at regular doses.

Exclusion Criteria

Contra-indications to anti-TNF treatment, imminent need for surgery.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this exploratory study will be the relationship between<br /><br>anti-TNF and TNF levels in serum, tissue and feces at different timepoints in<br /><br>patients with moderate to severe colitis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The correlation between primary response to those agents (clinical, biochemical<br /><br>en endoscopic improvement) and drug levels in these three compartments.</p><br>