REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorSint Maartenskliniek
About this trial
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 criteria
Qualifiers
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.)
Disqualifiers
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
Trial design
Treatments tested in this trial
- JAKi dose reduction strategy
- JAKi disease activity guided continuation of same dose strategy
Treatment groups
200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Sint Maartenskliniek
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov