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2024-511530-12-01CompletedPhase 4

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.

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Oct 2024

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Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
300 (actual)
First submitted
5 Sept 2024
Start date
1 Oct 2024
Lead sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
EU CT number
2024-511530-12-01
EudraCT number
2020-002802-21

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 300
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or previous treatment of arthritis with DMARDs
  • Glucocorticoids (GCs) in the 3 months prior to randomization

Lab values

  • (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.

Other

  • Unable to understand, speak and write in Dutch.

Who the study is looking for

  • Newly diagnosed, DMARD-naive RA patients, according to 2010 criteria
  • Age ≥18 years

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amphia HospitalBredaNetherlandsCompleted
IJsselland ZiekenhuisCapelle aan den IJsselNetherlandsCompleted
Albert Schweitzer ZiekenhuisDordrechtNetherlandsCompleted
Medisch Spectrum TwenteEnschedeNetherlandsCompleted
Admiraal De Ruyter Ziekenhuis B.V.GoesNetherlandsCompleted
Leids Universitair Medisch Centrum (LUMC)LeidenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsCompleted
Sint Franciscus Vlietland Groep StichtingRotterdamNetherlandsCompleted
Maasstad Ziekenhuis StichtingRotterdamNetherlandsCompleted
Haga Hospital's-GravenhageNetherlandsCompleted
Universitair Medisch Centrum UtrechtUtrechtNetherlandsCompleted

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.