Trough level related side-effects of adalimumab therapy in patients with inflammatory bowel disease in clinical and biochemical remission, a cross-sectional cohort study

Completed

• Conditions: 10017969; inflammatory bowel disease

• Registration Number: NL-OMON40963
• Lead Sponsor: Academisch Medisch Centrum

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: 40

Inclusion Criteria

IBD diagnose, in clinical and biochemical remission on adalimumab maintenance therapy

Exclusion Criteria

-biochemical parameters contradicting complete remission. (high fecal calprotectin and CRP)
-conditions or co-morbidities which could potentially cause symptoms like, fatigue, joint pain and skin lesions (such as infectious disease, arthritis, malignancy or pregnancy).
-detectable anti-bodies to adalimumab,

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is serum ADA trough level concentrations (the serum<br /><br>concentration just before the next injection).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>Secondary parameters are the skinscore, VAS-scores; Joint/Fatigue, the MFI,<br /><br>SF-36, FACIT and IBDQ.<br /><br>Other study parameters:<br /><br>Clinical Colitis Activity/Harvey Bradshaw Index, serum TSH, vitamin D, Hb,<br /><br>Leukocytes, Thrombocytes, CRP, Albumine and fecal calprotectin and baseline<br /><br>variables like age, gender, treatment characteristics, anatomic distribution<br /><br>and duration of disease.<br /><br></p><br>