Lowering JAK inhibitor doses in people with RA, PsA, or axSpA who are in low disease activity or remission
REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases
This study will test whether carefully lowering the dose of Janus kinase inhibitors keeps disease control as well as staying on the same dose in people with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who are in remission or have low disease activity.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Drugs / interventions | Baricitinib, Filgotinib, Tofacitinib, Upadacitinib |
| Locations | 7 sites (Nijmegen, Gelderland and 6 other locations) |
| Trial ID | NCT07160231 on ClinicalTrials.gov |
What this trial studies
This phase 4, non-inferiority randomized comparison will assign patients in sustained low disease activity or remission on JAK inhibitors to either a disease activity–guided dose reduction strategy or continuation of their current JAKi dose. Eligible participants are age 16 or older with RA, PsA, or axSpA, on at least 50% of the authorized JAKi dose and stable for at least six months. The primary endpoint is the proportion maintaining low disease activity at 12 months, with secondary outcomes including feasibility, safety, cost-effectiveness, and biomarker discovery. The study is conducted at several Dutch rheumatology centers and follows disease-activity guided decision rules for tapering or returning to previous doses.
Who should consider this trial
Good fit: Ideal candidates are people aged 16 or older with a clinical diagnosis of RA, PsA, or axSpA who have been on a JAK inhibitor at ≥50% of the authorized dose and have had low disease activity or remission for at least six months.
Not a fit: Patients with active disease, comorbid conditions that require ongoing JAKi treatment (for example active inflammatory bowel disease), pregnancy, short life expectancy, or inability to consent are unlikely to benefit from dose reduction in this protocol.
Why it matters
Potential benefit: If successful, patients could experience fewer drug-related side effects, lower infection and cost burden, and reduced long-term safety risks by using lower JAKi doses.
How similar studies have performed: Dose reduction strategies have been successfully used for other anti-rheumatic drugs, but disease activity–guided tapering specifically for JAK inhibitors is largely untested and the approach is novel for this drug class.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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.) Exclusion Criteria: * 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
Where this trial is running
Nijmegen, Gelderland and 6 other locations
- Sint Maartenskliniek Nijmegen — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (Not_yet_recruiting)
- Elisabeth-TweeSteden Ziekenhuis Tilburg — Tilburg, North Brabant, Netherlands (Not_yet_recruiting)
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Not_yet_recruiting)
- Isala Zwolle — Zwolle, Overijssel, Netherlands (Not_yet_recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
- Maasstad ziekenhuis — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.