NCT07160231RecruitingPhase 4
REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 1 May 2028
- Lead sponsor
- Sint Maartenskliniek
- NCT number
- NCT07160231
- EU CT number
- 2025-520757-36-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 15 Sept 2025 to the primary completion date, 1 May 2028
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis)
Other
- 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
Who the study is looking for
- 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.)
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reade revalidatie & reumatologie centrum te Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Recruiting |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Sint Maartenskliniek Stichting Coordinator of this site? Confirm its status | Ubbergen | Netherlands | Recruiting |
| Bernhoven B.V. Coordinator of this site? Confirm its status | Uden | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.