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Research project

PRIMERA trial

Status: Ongoing project

PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): A multicentre, open-label, randomized controlled trial comparing routine care with a tailor-made approach.

What we do

About our project

 The PRIMERA is a multicenter, open-label, randomized controlled trial with newly diagnosed rheumatoid arthritis (RA) patients. In this study we aim to compare the effectiveness of a tailor-made management approach with routine care from a clinical, patient’s as well as an economic point of view. In the tailor-made arm, medication alterations are considered more frequently than in the routine care arm, depending on the response to glucocorticoids and filgotinib, respectively Additionally, patients are stratified to receive a different initial csDMARD therapy based on their autoantibody status.  

The primary outcome for the clinical effectiveness consists of two parts; (1) the proportion of patients using a biological or synthetic targeted DMARD after 10 months of treatment and (2) disease activity score (DAS) over time. The primary outcome for the cost-effectiveness is the incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between both treatment approaches. 

Our research focus

Clinical and radiographic outcomes in RA have improved enormously due to early detection of the disease, early initiation of ‘intensive’ therapy and a treat-to-target approach. The emphasis on early diagnosis and treatment has led to the development of the 2010 ACR/EULAR classification criteria for RA. With the introduction of these new classification criteria, the heterogeneity of the RA disease spectrum has become more visible.

Despite this heterogeneity, current management recommendations still adopt a
‘one-size-fits-all’ treatment approach, where ideally individualized treatment, or personalized
medicine, is preferred. The prerequisite for personalized medicine is the ability to classify
individuals into subpopulations that differ in their response to a specific treatment, which for
RA still needs to be unraveled. However, we do believe that it is nowadays possible to
individualize RA management by taking into account the presence of autoantibodies and the quick response to glucocorticoids and targeted synthetic (ts)DMARDs.
 

Our team

Contact us: primera@erasmusmc.nl

 

Pascal de Jong, MD PhD

Agnes Looijen, MD

Judith Heutz, MD

Anke Nijs

Ron Buijs