Actively Recruiting

Phase 4
Age: 16Years +
All Genders
NCT07160231

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

Led by Sint Maartenskliniek · Updated on 2025-09-17

200

Participants Needed

7

Research Sites

137 weeks

Total Duration

On this page

Sponsors

S

Sint Maartenskliniek

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 16 years of age or older
  • Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA)
  • Currently treated with a Janus kinase inhibitor (JAKi) at a dose equal to or greater than 50% of the authorized dose
  • In low disease activity or remission for at least 6 months as defined by accepted criteria or treating rheumatologist and patient judgment (RA: DAS28-CRP < 2.9; PsA: PASDAS ≤ 3.2 and psoriasis mBSA involvement ≤ 3%; axSpA: ASDAS < 2.1)
Not Eligible

You will not qualify if you...

  • Presence of other health conditions requiring continued JAKi treatment, such as active Crohn's disease or ulcerative colitis
  • Life expectancy of 12 months or less
  • Pregnancy
  • Participation in other clinical trials that may interfere with this study
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Sint Maartenskliniek Nijmegen

Nijmegen, Gelderland, Netherlands, 6574 NA

Actively Recruiting

2

Maastricht UMC+

Maastricht, Limburg, Netherlands, 6229 HX

Not Yet Recruiting

3

Elisabeth-TweeSteden Ziekenhuis Tilburg

Tilburg, North Brabant, Netherlands, 5022 GC

Not Yet Recruiting

4

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands, 7512 KZ

Not Yet Recruiting

5

Isala Zwolle

Zwolle, Overijssel, Netherlands, 8025 AB

Not Yet Recruiting

6

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015 GD

Not Yet Recruiting

7

Maasstad ziekenhuis

Rotterdam, South Holland, Netherlands, 3079 DZ

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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