REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases

NCT07160231 | Recruiting Phase 4 DMC

• 2 other identifiers: T11722025-520757-36-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief 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 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.

Conditions

Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Axial Spondyloarthritis (AxSpA)

Keywords

disease activity guided dose reduction; Janus kinase inhibitors (JAKi); disease activity guided JAKi continuation

Outcome Measures

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.

  At 12 months of follow-up.

Secondary Outcomes (7)

• Mean DAS28-CRP for RA patients, PASDAS for PsA patients and ASDAS for AxSpA patients.

  At 6 and 12 months of follow up.

• Proportion of patients in intervention group at every dose reduction step.

  At 6 and 12 months of follow up.

• The proportion of patients developing adverse events in each study group.

  Through study completion, an average of 12 months

• The cumulative incidence of patients experiencing a flare.

  Through study completion, an average of 12 months

• Proportion of patients using comedication.

  At baseline and through study completion, an average of 12 months

Study Arms (4)

Dose reduction group (randomised)

EXPERIMENTAL

disease activity guided dose reduction strategy of JAKi

Drug: JAKi dose reduction strategy

Control group (randomised)

ACTIVE COMPARATOR

disease activity guided continuation of same dose strategy of JAKi (randomised)

Drug: JAKi disease activity guided continuation of same dose strategy

Dose reduction group (non-randomised)

EXPERIMENTAL

disease activity guided dose reduction strategy of JAKi

Drug: JAKi dose reduction strategy

Control group (non-randomised)

ACTIVE COMPARATOR

disease activity guided continuation of same dose strategy of JAKi

Drug: JAKi disease activity guided continuation of same dose strategy

Interventions

JAKi dose reduction strategy DRUG

JAKi dose reduction strategy

Dose reduction group (non-randomised); Dose reduction group (randomised)

JAKi disease activity guided continuation of same dose strategy DRUG

JAKi disease activity guided continuation of same dose strategy

Control group (non-randomised); Control group (randomised)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

Sint Maartenskliniek Nijmegen

Nijmegen, Gelderland, 6574 NA, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

NOT YET RECRUITING

Elisabeth-TweeSteden Ziekenhuis Tilburg

Tilburg, North Brabant, 5022 GC, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

NOT YET RECRUITING

Isala Zwolle

Zwolle, Overijssel, 8025 AB, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

Maasstad ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)