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REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases

RecruitingPhase 4Ages 16 Years - anyAllSint Maartenskliniek
NCT07160231 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to assess the effectiveness of a disease activity guided dose reduction strategy of Janus kinase inhibitor (JAKi) compared to disease activity guided JAKi continuation in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who are in a state of low disease activity or remission while on JAKi. The main question it aims to answer is: Is a disease activity guided dose reduction strategy for JAKi not inferior in terms of efficacy compared to disease activity guided JAKi continuation in patients with RA/PsA/axSpA that are currently in a low disease activity/remission state? Researchers will compare a disease activity guided dose reduction strategy for JAKi to disease activity guided JAKi continuation in patients with RA/PsA/axSpA that are currently in a low disease activity/remission state to see if a dise

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients ≥ 16 years of age * Clinical diagnosis of RA, PsA or axSpA * Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose) * LDA or remission for at least 6 months according to accepted criteria for the specific disease and/or the judgement of the treating rheumatologist and patient. (RA: DAS28-CRP \< 2.9; PsA: PASDAS ≤3.2 and psoriasis mBSA involvement ≤3%; axSpA: ASDAS \<2.1.) Exclusion Criteria: * Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis) * Life expectancy ≤12 months * Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant) * Patients who are enrolled in other trials that might mutually interfere * Not able to provide informed consent
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What it tests

  • JAKi dose reduction strategy
  • JAKi disease activity guided continuation of same dose strategy
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Where

7 sites
Sint Maartenskliniek Nijmegen
Nijmegen, Netherlands
Maastricht UMC+
Maastricht, Netherlands
Elisabeth-TweeSteden Ziekenhuis Tilburg
Tilburg, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Isala Zwolle
Zwolle, Netherlands
Erasmus MC
Rotterdam, Netherlands
Maasstad ziekenhuis
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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