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Clinical Trials in the Netherlands / NCT07160231
Recruiting Phase 4

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

NCT07160231 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Sint Maartenskliniek
Phase
Phase 4
Started
2025-09-15
Last updated
2025-09-17

Condition(s) studied

Rheumatoid Arthritis (RA)Psoriatic Arthritis (PsA)Axial Spondyloarthritis (AxSpA)

Investigational drug(s) / intervention(s)

JAKi dose reduction strategyJAKi disease activity guided continuation of same dose strategy

JAKi dose reduction strategy: JAKi dose reduction strategy

JAKi disease activity guided continuation of same dose strategy: JAKi disease activity guided continuation of same dose strategy

Study 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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Sint Maartenskliniek Nijmegen Nijmegen Gelderland Recruiting
Maastricht UMC+ Maastricht Limburg Not Yet Recruiting
Elisabeth-TweeSteden Ziekenhuis Tilburg Tilburg North Brabant Not Yet Recruiting
Medisch Spectrum Twente Enschede Overijssel Not Yet Recruiting
Isala Zwolle Zwolle Overijssel Not Yet Recruiting
Erasmus MC Rotterdam South Holland Not Yet Recruiting
Maasstad ziekenhuis Rotterdam South Holland Not Yet Recruiting

More Sint Maartenskliniek trials in the Netherlands

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse Active, not recruiting
Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors Recruiting
TrEatment Targets in Rheumatoid Arthritis: TETRA-study Active, not recruiting
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements Recruiting
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis Recruiting

Other trials for the same condition

Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors Recruiting
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160231 on ClinicalTrials.gov ↗ ← All trials in the Netherlands