Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial
- Conditions
- Rheumatoid arthritis10003816
- Registration Number
- NL-OMON55177
- Lead Sponsor
- Reade
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 89
Inclusion Criteria
Rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
Treated for at least 28 weeks with adalimumab
Adalimumab trough concentration >5mg/L
Who has agreed to participate (written informed consent);
Age 16 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;
No 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 primary study endpoint is the difference in mean time weighted DAS28-CRP<br /><br>between week 0 and 24.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Difference in mean time weighted DAS28-CRP between study groups after 12 weeks<br /><br>Direct medical costs (medication, non-scheduled visits due flares, cost TDM<br /><br>testing) over 24 weeks<br /><br>Agreement between algorithm predicted and measured adalimumab concentrations at<br /><br>week 24.<br /><br>Number of flares and dose-interval shortenings after 24 weeks.</p><br>