Comparing the effectiveness of our tailor-made management approach with routine care from a clinical, patient's as well as an economic point of view. Tailoring of treatment is done by taking the presence of autoantibodies and the quick response to glucocorticoids and JAK inhibitors into account.

Trial details

Who runs it

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Trial code

EU 2024-511530-12-01

Record updated

2024. október 1.

Original description

The primary outcomes for the clinical effectiveness consists of 2 parts, namely the difference in (1) proportion of patients using a b- or tsDMARD after 10 months of treatment and (2) disease activity, measured with the disease activity score (DAS) over time. Our tailormade management approach is superior to routine care if (very) low disease activity is attained faster without the use of more b- or tsDMARDs (expensive drugs).Read full original descriptionShow less

PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): a multicenter, open-label, randomized controlled trial comparing usual care with a tailor-made approach

The primary outcomes for the clinical effectiveness consists of 2 parts, namely the difference in (1) proportion of patients using a b- or tsDMARD after 10 months of treatment and (2) disease activity, measured with the disease activity score (DAS) over time. Our tailormade management approach is superior to routine care if (very) low disease activity is attained faster without the use of more b- or tsDMARDs (expensive drugs).

The primary outcome for the cost-effectiveness analysis will be the incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between both management approaches.

Inclusion: Newly diagnosed, DMARD-naive RA patients, according to 2010 criteria; Age ≥18 years.

Exclusion: Current or previous treatment of arthritis with DMARDs; Glucocorticoids (GCs) in the 3 months prior to randomization; (Relative) contraindications for study medication: a. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional. b. Pregnant or nursing (lactating) women c. Female participants of child bearing potential and male participants whose partner is of child bearing potential who are not willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice. d. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/randomization, to rule out laboratory error. e. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min. f. Other underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy; Unable to understand, speak and write in Dutch.

EU CTIS 2024-511530-12-01