REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
Recruiting · NCT07160231 · Interventional (participants receive a specific treatment) · Lead sponsor: Sint Maartenskliniek
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.)
Exclusion criteria
- Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis)
- Life expectancy ≤12 months
- Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant)
- Patients who are enrolled in other trials that might mutually interfere
- Not able to provide informed consent
Where it is running
14 locations listed.
- Sint Maartenskliniek Nijmegen - Nijmegen, Gelderland, Netherlands
- Sint Maartenskliniek Nijmegen - Nijmegen, Gelderland, Netherlands
- Maastricht UMC+ - Maastricht, Limburg, Netherlands
- Maastricht UMC+ - Maastricht, Limburg, Netherlands
- Elisabeth-TweeSteden Ziekenhuis Tilburg - Tilburg, North Brabant, Netherlands
- Elisabeth-TweeSteden Ziekenhuis Tilburg - Tilburg, North Brabant, Netherlands
- Medisch Spectrum Twente - Enschede, Overijssel, Netherlands
- Medisch Spectrum Twente - Enschede, Overijssel, Netherlands
- Isala Zwolle - Zwolle, Overijssel, Netherlands
- Isala Zwolle - Zwolle, Overijssel, Netherlands
- Erasmus MC - Rotterdam, South Holland, Netherlands
- Maasstad ziekenhuis - Rotterdam, South Holland, Netherlands
- Erasmus MC - Rotterdam, South Holland, Netherlands
- Maasstad ziekenhuis - Rotterdam, South Holland, Netherlands