Actively Recruiting
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
Eligibility Criteria
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)
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
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
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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