Trough level-based dose reduction during infliximab maintenance treatment in Crohn*s disease

Phase 4

Withdrawn

• Conditions: Crohn's disease; Morbus Crohn; 10017969

• Registration Number: NL-OMON40729
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

-Diagnosis of CD based on endoscopy and pathology
-18 years or older
-At least 6 months in remission, defined as:
---Harvey Bradshaw Index *4,
---Normal serum C-reactive protein (CRP) level (<5 mg/l), and
---Low fecal calprotectin level (< 250 ug/g)
-IFX therapy >6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression (stable for > 3 months).
-IFX TL > 7 ug/ml.

Exclusion Criteria

-Non-adherence to the 8 weekly infusions schedule in the past
-Participation in another therapeutic trial
-Prior dose adjustments or interval shortening of IFX

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with sustained clinical remission</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Proportion of patients with clinical and biochemical relapse; Time to relapse;<br /><br>Presence of predictive factors for successful IFX dose reduction with specific<br /><br>focus on smoking status, body mass index and extent of disease; Laboratory<br /><br>tests (CRP and fecal calprotectin) at all study visits; Adverse events;<br /><br>Economic evaluation; Pharmaco-economic evaluation; Quality of life; Yearly<br /><br>total IFX dose per patient.</p><br>