Rheumatoid Arthritis (RA)Phase 4REDO-JAKNCT07160231
REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
A Phase 4 study testing JAKi dose reduction strategy and JAKi disease activity guided continuation of same dose strategy in people with Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), run by Sint Maartenskliniek at 7 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Axial Spondyloarthritis (AxSpA)
- What is being tested?
- JAKi dose reduction strategy and JAKi disease activity guided continuation of same dose strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesNetherlands
- Study dates
- 15 Sep 2025to 1 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Not yet recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
Prof dr. H. Vonkeman, h.vonkeman@mst.nl
- Not yet recruiting
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Prof dr. A. van Tubergen, a.van.tubergen@mumc.nl
- Recruiting
Sint Maartenskliniek Nijmegen
Nijmegen, Gelderland, 6574 NA
Dr. N. van Herwaarden, +31 24 365 94 09, n.vanherwaarden@maartenskliniek.nl
- Not yet recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Dr. P.H.P. de Jong, p.h.p.dejong@erasmusmc.nl
- Not yet recruiting
Maasstad ziekenhuis
Rotterdam, South Holland, 3079 DZ
Dr. M. Kok, kokmr@maasstadziekenhuis.nl
- Not yet recruiting
Elisabeth-TweeSteden Ziekenhuis Tilburg
Tilburg, North Brabant, 5022 GC
Dr. L Schipper, l.schipper@etz.nl
- Not yet recruiting
Isala Zwolle
Zwolle, Overijssel, 8025 AB
Dr A.E. van der Bijl, a.e.van.der.bijl@isala.nl
About this study
Official title: REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
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?
Read more
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.
Read the detailed description
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.
- Being tested
- JAKi dose reduction strategy, JAKi disease activity guided continuation of same dose strategy
- Keywords
- disease activity guided dose reduction, Janus kinase inhibitors (JAKi), disease activity guided JAKi continuation
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAKi dose reduction strategyDrug
JAKi dose reduction strategy
JAKi disease activity guided continuation of same dose strategyDrug
JAKi disease activity guided continuation of same dose strategy
| Study group | Role | What they receive |
|---|---|---|
| Dose reduction group (randomised) | Experimental | disease activity guided dose reduction strategy of JAKi Receives: Drug: JAKi dose reduction strategy |
| Control group (randomised) | Active comparator | disease activity guided continuation of same dose strategy of JAKi (randomised) Receives: Drug: JAKi disease activity guided continuation of same dose strategy |
| Dose reduction group (non-randomised) | Experimental | disease activity guided dose reduction strategy of JAKi Receives: Drug: JAKi dose reduction strategy |
| Control group (non-randomised) | Active comparator | disease activity guided continuation of same dose strategy of JAKi Receives: Drug: JAKi disease activity guided continuation of same dose strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months of follow-up.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Sep 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This open label study is a partially randomised patient preference trial (PRPPT), also known as comprehensive cohort study (CCS). The PRPPT design includes two subtrials that will subsequently be pooled to derive a single treatment effect estimate. The first is a pragmatic randomised controlled trial including participants who consent to randomisation. In addition, a non-randomised trial is done using the same intervention, control arm and outcome assessments, but allocation based on patient preferences.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160231
- Sponsor's protocol ID
- T1172
- Other IDs
- 2025-520757-36-00, 2025
- Acronym
- REDO-JAK
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT07160231
- Acronym / sponsor ID
- REDO-JAK / T1172
- Keywords
- disease activity guided dose reduction, Janus kinase inhibitors (JAKi), disease activity guided JAKi continuation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This open label study is a partially randomised patient preference trial (PRPPT), also known as comprehensive cohort study (CCS). The PRPPT design includes two subtrials that will subsequently be pooled to derive a single treatment effect estimate. The first is a pragmatic randomised controlled trial including participants who consent to randomisation. In addition, a non-randomised trial is done using the same intervention, control arm and outcome assessments, but allocation based on patient preferences.
| Arm | Type | Receives |
|---|---|---|
| Dose reduction group (randomised) | Experimental | Drug: JAKi dose reduction strategydisease activity guided dose reduction strategy of JAKi |
| Control group (randomised) | Active comparator | Drug: JAKi disease activity guided continuation of same dose strategydisease activity guided continuation of same dose strategy of JAKi (randomised) |
| Dose reduction group (non-randomised) | Experimental | Drug: JAKi dose reduction strategydisease activity guided dose reduction strategy of JAKi |
| Control group (non-randomised) | Active comparator | Drug: JAKi disease activity guided continuation of same dose strategydisease activity guided continuation of same dose strategy of JAKi |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAKi dose reduction strategyJAKi dose reduction strategy | Drug | Dose reduction group (non-randomised), Dose reduction group (randomised) |
| JAKi disease activity guided continuation of same dose strategyJAKi disease activity guided continuation of same dose strategy | Drug | Control group (non-randomised), Control group (randomised) |
Primary outcome
The proportion of patients in low disease activity (LDA) at 12 months of follow-up in each study group.
Time frame: At 12 months of follow-up.
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.
7 secondary outcomes
Mean DAS28-CRP for RA patients, PASDAS for PsA patients and ASDAS for AxSpA patients.
Time frame: At 6 and 12 months of follow up.
Proportion of patients in intervention group at every dose reduction step.
Time frame: At 6 and 12 months of follow up.
The proportion of patients developing adverse events in each study group.
Time frame: Through study completion, an average of 12 months
The cumulative incidence of patients experiencing a flare.
Time frame: Through study completion, an average of 12 months
Proportion of patients using comedication.
Time frame: At baseline and through study completion, an average of 12 months
The incremental cost effectiveness ratio
Time frame: Through study completion, an average of 12 months
Association between possible predictors and outcome.
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sint Maartenskliniek Nijmegen
Nijmegen, Netherlands
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JAKi dose reduction strategy and JAKi disease activity guided continuation of same dose strategy in people with Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), run by Sint Maartenskliniek at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in low disease activity (LDA) at 12 months of follow-up in each study group. (time frame: At 12 months of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.