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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
JAKi dose reduction strategy
DrugJAKi dose reduction strategy
JAKi disease activity guided continuation of same dose strategy
DrugJAKi disease activity guided continuation of same dose strategy
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Dose reduction group (randomised)Experimental treatment 1 intervention
Group B: Control group (randomised)Active comparator 1 intervention
Group C: Dose reduction group (non-randomised)Experimental treatment 1 intervention
Group D: Control group (non-randomised)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients in low disease activity (LDA) at 12 months of follow-up in each study group.
The proportion of patients in low disease activity (LDA) at 12 months of follow-up in each study group. LDA is defined as DAS28-CRP \< 2.9 for RA patients, PASDAS \< 3.2 and mBSA involvement ≤3% for PsA and ASDAS \< 2.1 and an absence of active extra musculoskeletal symptoms for axSpA.
Time frame
At 12 months of follow-up.Secondary outcomes
1
Mean DAS28-CRP for RA patients, PASDAS for PsA patients and ASDAS for AxSpA patients.
Mean DAS28-CRP for RA patients, PASDAS for PsA patients and ASDAS for AxSpA patients at 6 and 12 months of follow up in each study group.
Time frame
At 6 and 12 months of follow up.2
Proportion of patients in intervention group at every dose reduction step.
Proportion of patients in intervention group at every dose reduction step (including discontinuation) at 6 and 12 months of follow up.
Time frame
At 6 and 12 months of follow up.3
The proportion of patients developing adverse events in each study group.
The proportion (cumulative incidence and incidence density) of patients developing (treatment-related) adverse events in each study group over the duration of the study, with special attention to infections, anaemia, cardiovascular events, VTE and malignancies.
Time frame
Through study completion, an average of 12 months4
The cumulative incidence of patients experiencing a flare.
The cumulative incidence of patients experiencing a flare in each study group over the duration of the study.
Time frame
Through study completion, an average of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sint Maartenskliniek
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov