sing adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): a blinded randomized superiority trail
- Conditions
- 10003816Rheumatoide arthritis
- Registration Number
- NL-OMON52747
- Lead Sponsor
- Reade
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
Rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
Failed treatment with adalimumab (defined as DAS28-CRP >2,9) and not treated
with a subsequent biological DMARD (bDMARD) or target synthetic DMARD (tsDMARD)
Who has agreed to participate (written informed consent);
Age 18 years or older.
Received adalimumab for at least 10 weeks in standard dosing (40mg
subcutaneously every other week, either in monotherapy or combined with
methotrexate or leflunomide)
Stop adalimumab due to inefficacy, either alone or combined with side effects
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 possibility to safely receive an TNF-inhibitor or a non-TNF-inhibitor '
Treatment with another TNF inhibitor prior to adalimumab
Treatment with all non-TNFi options (abatacept, rituximab, sarilumab,
tocilizumab, baricitinib, filgotinib, upadacitinib or tofacitinib) prior to
adalimumab
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>after 24 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• percentage of patients with good or moderate response according the EULAR<br /><br>response criteria after 12 and 24 weeks of treatment<br /><br>• percentage of patients with minimal disease activity (DAS28-CRP<2.9) after 24<br /><br>weeks<br /><br>• percentage of non-responders to the subsequent biological after 24 weeks<br /><br>• number of flares after 24 weeks<br /><br>• numbers and severity of adverse events<br /><br>• use of co-medication/rescue medication use</p><br>