Adalimumab dose optimisation in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-centre open label randomised controlled trail
Recruiting
- Conditions
- rheumatoid arthritis10003816
- Registration Number
- NL-OMON47985
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 267
Inclusion Criteria
Rheumatoid arthritis patient, according to ACR 1987 /2010 criteria;
Starting adalimumab as the first biological therapy
Written informed consent
Age 18 years or older.
Exclusion Criteria
Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation;
Life expectancy shorter than follow-up period of the study;
Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main parameter used to investigate the primary objective is direct medical<br /><br>costs associated with adalimumab dose reduction strategies (medication,<br /><br>non-scheduled visits due flares, cost TDM testing) over 52 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Difference in mean time weighted DAS28-CRP between study groups at 16, 28, 52<br /><br>and 80 weeks.<br /><br>Direct medical costs (medication, visits, cost TDM testing) of both study<br /><br>groups after 28, 40 and 80 weeks.<br /><br>Indirect medical costs of both study group at 52 and 80 weeks of treatment.<br /><br>Percentage of patients with DAS28-CRP<2.9 in both study groups at 52 and 80<br /><br>weeks.<br /><br>Number of flares and dose-interval shortenings in both study groups at 52 and<br /><br>80 weeks.<br /><br>Agreement between algorithm predicted and measured adalimumab concentrations at<br /><br>week 28 and week 52 (only drug concentration guided group). </p><br>