drugset / Trial / NCT07160231

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

NCT07160231

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-15
Primary completion
2028-05-01
Completion
2028-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 2 mg
Subject Baricitinib Small molecule 4 mg
Subject Filgotinib Small molecule 100 mg
Subject Filgotinib Small molecule 200 mg
Subject Tofacitinib Small molecule 5 mg
Subject Tofacitinib Small molecule 11 mg
Subject Upadacitinib Small molecule 15 mg