A Phase 4 interventional study of JAKi dose reduction strategy and JAKi disease activity guided continuation of same dose strategy in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (AxSpA), sponsored by Sint Maartenskliniek. Recruiting at 7 sites in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Sint Maartenskliniek · Phase 4, Interventional, and Treatment
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:
Rationale Janus kinase inhibitors (JAKi) are used in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Despite their proven effectiveness, use of these drugs increases the risk of infections and is costly. In addition, there have been recent warnings that JAKi may increase the risk of cardiovascular disease and cancer. For other anti-rheumatic drugs, disease activity guided dose reduction has been shown to be safe and cost-effective while reducing side effects. This has not yet been studied for JAK inhibitors, while it is very relevant given the concerns regarding side effects and costs of the drugs.
Objective The primary objective of this project is to assess the effectiveness of a disease activity guided dose reduction strategy of JAKi compared to disease activity guided JAKi continuation in patients with RA, PsA and axSpA who are in a state of low disease activity or remission while on JAKi. Key secondary objectives are to assess feasibility of the proposed dose reduction strategies, safety, cost-effectiveness and the identification of possible predictive biomarkers for (un)successful dose reduction or discontinuation of JAKi.
Main trial endpoints The main trial endpoint is the non-inferiority of the difference in the proportion of people with low disease activity between the dose reduction group and the continuation group after 12 months compared to the non-inferiority margin.
Secondary trial endpoints Secondary trial endpoints include the proportion of people in the intervention group able to reduce and/or discontinue their JAKi, cost-effectiveness of the dose reduction strategy compared to the continuation strategy, and between group differences in the incidence of disease flares, difference in functioning, quality of life, pain, fatigue, safety and costs.
Trial design This open label study is a partially randomised patient preference trial, also known as a comprehensive cohort study. Participants will be randomised (2:1 ratio) to step-by-step dose reduction or continuation of standard dosing. If potential participants have a strong preference for a specific group and do not wish to be randomised, they will be given the opportunity to choose their group. Follow up for and individual patient is this trial will be 12 months.
Trial population Patients ≥ 16 year, with a clinical diagnosis of RA, PsA or axSpA who use a JAK inhibitor and have low disease activity.
Interventions The intervention group reduces their JAKi dose stepwise every three months. In the event of a flare of disease activity, the dose is increased to the latest effective dose and kept stable until the end of follow-up.
A dose reduction scheme is created for each JAKi for patients allocated to the intervention group:
For patients using:
Baricitinib 4 mg once daily Dose reduction step 1 (baseline); 2 mg once daily (splitting 4 mg tablet) Dose reduction step 2 (3 months); 1 mg once daily (splitting 2 mg tablet) Dose reduction step 3 (6 months); Discontinuation
Baricitinib 2 mg once daily Dose reduction step 1 (baseline) 1 mg once daily (splitting 2 mg tablet) Dose reduction step 2 (3 months); Discontinuation
Filgotinib 200 mg once daily Dose reduction step 1 (baseline); 100 mg once daily (splitting 200 mg tablet) Dose reduction step 2 (3 months); 50 mg once daily (splitting 100 mg tablet) Dose reduction step 3 (6 months); Discontinuation
Filgotinib 100 mg once daily Dose reduction step 1 (baseline); 50 mg once daily (splitting 100 mg tablet) Dose reduction step 2 (3 months); Discontinuation
Tofacitinib 5 mg twice daily OR Tofacitinib 11 mg once daily Dose reduction step 1 (baseline); 5 mg once daily Dose reduction step 2 (3 months); 2.5 mg once daily (splitting 5mg tablet) Dose reduction step 3 (6 months); Discontinuation
Tofacitinib 5 mg once daily Dose reduction step 1 (baseline); 2.5 mg once daily (splitting 5mg tablet) Dose reduction step 2 (3 months); Discontinuation
Upadacitinib 15 mg once daily Dose reduction step 1 (baseline); 7.5 mg once daily (splitting 15 mg tablet) Dose reduction step 2 (3 months); 7.5 mg every other day (splitting 15 mg tablet) Dose reduction step 3 (6 months); Discontinuation
The control group continues treatment following usual care. All participants are monitored every 3 months. For both trial arms, additional visits can be scheduled in between planned visits in case of complaints. In case of flare treatment will be intensified.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 200 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sint Maartenskliniek is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
disease activity guided dose reduction strategy of JAKi
Drug: JAKi dose reduction strategy
disease activity guided continuation of same dose strategy of JAKi (randomised)
Drug: JAKi disease activity guided continuation of same dose strategy
disease activity guided dose reduction strategy of JAKi
Drug: JAKi dose reduction strategy
disease activity guided continuation of same dose strategy of JAKi
Drug: JAKi disease activity guided continuation of same dose strategy
JAKi dose reduction strategy
JAKi disease activity guided continuation of same dose strategy
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.
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.
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.
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 months
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 months
Proportion of patients using comedication.
Proportion of patients using csDMARD, corticosteroids or NSAIDs at baseline, and starting/changing these treatments during follow-up.
Time frame: At baseline and through study completion, an average of 12 months
The incremental cost effectiveness ratio
Quality of life and costs incurred during the study will be compared between the study groups. The incremental cost effectiveness ratio will be calculated using incremental (between-group) costs and quality of life, and compared with different willingness to pay thresholds.
Time frame: Through study completion, an average of 12 months
Association between possible predictors and outcome.
Association between possible predictors and outcome. Predictors will include baseline peak and trough JAKi concentrations and whole blood/PBMC immunophenotyping.
Time frame: Through study completion, an average of 12 months
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for May 2028, 31 months after the start.
Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's planned 31 months is below that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
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Sint Maartenskliniek