Study of the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease; 10017969

• Registration Number: NL-OMON44551
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-31
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Age from 18 years, either male or female
-Moderate to severe Ulcerative Colitis (according to Mayo score (2 or 3) baseline Colonoscopy), both anti-TNF naïve and anti-TNF exposed patients will be included
-Baseline endoscopy
-Obtained written informed consent

Exclusion Criteria

- Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
- Imminent need for surgery

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Drug level of golimumab at several time points.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Development of anti-drug antibodies, fecal calprotectin, fecal golimumab drug<br /><br>levels, serum CRP, albumin level, SCCAI, IBDQ, SF-36 and endoscopies at<br /><br>different time points. </p><br>