RecruitingPhase 4NCT07160231

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

REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases


Sponsor

Sint Maartenskliniek

Enrollment

200 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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 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 disease activity guided dose reduction strategy for JAKi is not inferior in terms of efficacy compared to disease activity guided JAKi continuation. Participants will: * Follow a JAKi dose reduction strategy or will continue using JAKi in the same dose * Study (telemonitoring) visits are planned every 3 months * At every visit, patients are asked to complete patient-reported outcomes that assess daily functioning, health-related quality of life, pain, fatigue, productivity loss, medical consumption and medication adherence.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether people with inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis) who are in remission or low disease activity on JAK inhibitor medications can safely reduce their dose. Lowering the dose could reduce long-term side effects while maintaining disease control. **You may be eligible if...** - You are 16 or older - You have been diagnosed with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) - You are taking a JAK inhibitor (at least half the standard approved dose) - Your disease has been in remission or low activity for at least 6 months **You may NOT be eligible if...** - You have another condition that requires you to stay on the current JAK inhibitor dose (e.g., active Crohn's disease or ulcerative colitis) - Your life expectancy is 12 months or less - You are pregnant (JAK inhibitors are contraindicated in pregnancy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJAKi dose reduction strategy

JAKi dose reduction strategy

DRUGJAKi disease activity guided continuation of same dose strategy

JAKi disease activity guided continuation of same dose strategy


Locations(7)

Sint Maartenskliniek Nijmegen

Nijmegen, Gelderland, Netherlands

Maastricht UMC+

Maastricht, Limburg, Netherlands

Elisabeth-TweeSteden Ziekenhuis Tilburg

Tilburg, North Brabant, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Isala Zwolle

Zwolle, Overijssel, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

Maasstad ziekenhuis

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07160231


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