Study of the pharmacokinetics of Infliximab (IFX) in moderate to severe Ulcerative Colitis

Completed

• Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; 10017969

• Registration Number: NL-OMON37516
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-04-03
• Last Update Posted: 29 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) naïve to biologic therapy.
-Baseline Colonoscopy
-Obtained written informed consent

Exclusion Criteria

-History of anti-TNF treatment
-Contra-indication to infliximab: TBC, severe infections or congestive heart failure.
-Imminent need for surgery
-Immunomodulators started in the last 4 weeks

Study & Design

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Development of antibodies, fecal calprotectin en serum CRP, Albumine level,<br /><br>Simple Clinical Colitis Activity Index, colonoscopy and biopsies at the<br /><br>different time points</p><br>