owering infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Lowering Infliximab in IBD patients in sustained Remission, the LIR study

Recruiting

• Conditions: Inflammatory Bowel Disease; 10017969

• Registration Number: NL-OMON44819
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Age 18 or above
Written informed consent
Patients with ulcerative colitis or ileocolonic Crohn*s disease, treated with infliximab (IFX), dosed at 5mg/kg, regardless of dosing interval
In sustained clinical remission for at least 12 months whilst being treated with infliximab
Full clinical response and disease control, defined as
-Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
-Fecal calprotectin < 250 µg/g and CRP within normal range

Exclusion Criteria

Concomitant corticosteroid usage
Imminent need for IBD-related surgery
Actively draining perianal fistula
Pregnancy or lactation
Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of patients in remission, 12 months after inclusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Number of relapses, defined by increase of fecal calprotectin and/or CRP and<br /><br>clinical activity and subsequently confirmed by endoscopy in patients with and<br /><br>without dose adjustments<br /><br>Cost-effectiveness of IFX dose adjustments</p><br>