therapeutic drug monitoring: towards tailored dosing of adalimumab in rheumatoid arthritis

Completed

• Conditions: rheumatoide arthritis; 10003816

• Registration Number: NL-OMON41716
• Lead Sponsor: Reade, centrum voor Revalidatie en Reumatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-31
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

RA according to the ACR 1987 criteria
Adalimumab treatment for at least 28 weeks
Trough adalimumab level > 12 mg/L
Treating rheumatologist is convinced of the benefit of adalimumab continuation
Written informed consent

Exclusion Criteria

Scheduled surgery in the next 6 months or other pre planned reasons for treatment discontinuation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Similar *DAS28 in patients with high serum adalimumab concentrations who are<br /><br>randomly assigned to continuation of the regular dose or to dose interval<br /><br>prolongation. A clinically relevant difference in disease activity is defined<br /><br>as a *DAS28 > 0.6. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cost-effectiveness of therapeutic drug monitoring in rheumatoid arthritis<br /><br>patients responding to adalimumab.</p><br>