Status:
RECRUITING
REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
Lead Sponsor:
Sint Maartenskliniek
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Rheumatoid Arthritis (RA)
Psoriatic Arthritis (PsA)
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
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 continuati...
Detailed Description
Rationale Janus kinase inhibitors (JAKi) are used in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Despite their proven effectiveness, use...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07160231
Start Date
September 15 2025
End Date
May 1 2028
Last Update
September 17 2025
Active Locations (7)
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1
Sint Maartenskliniek Nijmegen
Nijmegen, Gelderland, Netherlands, 6574 NA
2
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX
3
Elisabeth-TweeSteden Ziekenhuis Tilburg
Tilburg, North Brabant, Netherlands, 5022 GC
4
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512 KZ