Adalimumab drug optimisation in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-centre open label randomised controlled trail
Recruiting
- Conditions
- Rheumatoid arthritis
- Registration Number
- NL-OMON26185
- Lead Sponsor
- Reade Rheumatology Research Institute
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 267
Inclusion Criteria
Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria;
Starting adalimumab as the first biological therapy
Who has agreed to participate (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 The main objective is to evaluate whether adalimumab dose reduction using adalimumab serum concentration will minimize medical costs, compared to disease activity guided dose reduction in rheumatoid arthritis patients
- Secondary Outcome Measures
Name Time Method The secondary objectives are to investigate the percentage of patients reaching minimal disease activity (DAS28-CRP<2.9) in both study arms; to study the difference in cumulative incidence of flares between the study arms; to evaluate the algorithm used to prolong the dosing interval based on adalimumab concentration; to study the difference in cumulative incidence of flares between both arm after discontinuation of treatment after 52 weeks and 80 weeks