REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.)

Locations
Other Locations
Netherlands
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
Maastricht UMC+
NOT_YET_RECRUITING
Maastricht
Sint Maartenskliniek Nijmegen
RECRUITING
Nijmegen
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Maasstad ziekenhuis
NOT_YET_RECRUITING
Rotterdam
Elisabeth-TweeSteden Ziekenhuis Tilburg
NOT_YET_RECRUITING
Tilburg
Isala Zwolle
NOT_YET_RECRUITING
Zwolle
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 200
Treatments
Experimental: Dose reduction group (randomised)
disease activity guided dose reduction strategy of JAKi
Active_comparator: Control group (randomised)
disease activity guided continuation of same dose strategy of JAKi (randomised)
Experimental: Dose reduction group (non-randomised)
disease activity guided dose reduction strategy of JAKi
Active_comparator: Control group (non-randomised)
disease activity guided continuation of same dose strategy of JAKi
Sponsors
Leads: Sint Maartenskliniek
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov