Lowering JAK inhibitor doses in people with RA, PsA, or axSpA who are in low disease activity or remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, non-inferiority randomized comparison will assign patients in sustained low disease activity or remission on JAK inhibitors to either a disease activity–guided dose reduction strategy or continuation of their current JAKi dose. Eligible participants are age 16 or older with RA, PsA, or axSpA, on at least 50% of the authorized JAKi dose and stable for at least six months. The primary endpoint is the proportion maintaining low disease activity at 12 months, with secondary outcomes including feasibility, safety, cost-effectiveness, and biomarker discovery. The study is conducted at several Dutch rheumatology centers and follows disease-activity guided decision rules for tapering or returning to previous doses.

Why it matters

Who can join: the full rules

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

Where it's running

• Sint Maartenskliniek Nijmegen
  Nijmegen, Gelderland, Netherlands Recruiting
• Maastricht UMC+
  Maastricht, Limburg, Netherlands Not yet recruiting
• Elisabeth-TweeSteden Ziekenhuis Tilburg
  Tilburg, North Brabant, Netherlands Not yet recruiting
• Medisch Spectrum Twente
  Enschede, Overijssel, Netherlands Not yet recruiting
• Isala Zwolle
  Zwolle, Overijssel, Netherlands Not yet recruiting
• Erasmus MC
  Rotterdam, South Holland, Netherlands Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.