Actively Recruiting
REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis
Led by Sint Maartenskliniek · Updated on 2025-09-17
200
Participants Needed
7
Research Sites
N/A
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
Researchers are evaluating whether reducing the dose of Janus kinase inhibitors (JAKi) based on disease activity is as effective as continuing the same dose in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) who currently have low disease activity or are in remission. This study addresses concerns about the risks and costs associated with JAKi treatment, including infection, cardiovascular disease, and cancer. The study also aims to assess feasibility, safety, cost-effectiveness, and identify biomarkers related to dose reduction success. Participants will be assigned either to a stepwise JAKi dose reduction group or to continue their current JAKi dose. Dose reductions occur every three months with specific tapering steps outlined for different JAKi medications, such as Baricitinib, Filgotinib, Tofacitinib, and Upadacitinib. If disease activity flares, the dose is increased back to the last effective level and maintained. The control group continues usual care with their standard dosing. All participants are monitored every three months, with additional visits if needed. During the 12-month follow-up, participants complete questionnaires every three months about their daily functioning, quality of life, pain, fatigue, productivity, medical use, and medication adherence. Researchers will measure the proportion of patients maintaining low disease activity, disease activity scores specific to each condition, adverse events, flare incidence, medication use, cost-effectiveness, and potential predictors for successful dose reduction. The study includes telemonitoring visits and allows for treatment adjustment in response to symptoms.
CONDITIONS
Brief 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, psoriatic arthritis, or axial spondyloarthritis
- Currently treated with a Janus kinase inhibitor at 50% or more of the authorized dose
- Low disease activity or remission for at least 6 months based on accepted criteria or doctor and patient judgment
You will not qualify if you...
- Having another disease requiring continued Janus kinase inhibitor treatment, such as active Crohn's disease or ulcerative colitis
- Life expectancy less than or equal to 12 months
- Pregnancy
- Participation in other clinical trials that could interfere with this study
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants either follow a stepwise dose reduction of their Janus kinase inhibitors every three months or continue their usual dose. Dose adjustments occur based on disease activity, with visits every 3 months and additional visits if needed for disease flares.
Quarterly visits every 3 months with additional visits as needed
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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