Actively Recruiting

Phase 4
Age: 16Years +
All Genders
ID07160231

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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