REDO-JAK: Dose REDuction Of JAnus Kinase inhibitors in patients with inflammatory rheumatic diseases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Maartenskliniek Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

15 Sep 2025 → ongoing

Decision date (initial)

2025-07-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

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?

Secondary objectives 7

1. Is there a difference in disease activity between both groups, subdivided by disease?
2. How many participants are able to reduce their dose and/or discontinue their JAKi?
3. Is there a difference in safety endpoints between both study groups?
4. Is there a difference in incidence of flares between both groups?
5. How many participants use NSAIDs, corticosteroids and csDMARDs?
6. Is the proposed dose reduction strategy cost-effective compared to usual care?
7. Can we identify predictive biomarkers for (un)successful dose reduction or discontinuation?

Conditions and MedDRA coding

Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients ≥ 16 years of age
2. Clinical diagnosis of RA, PsA or axSpA
3. Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose)
4. 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 5

1. Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn’s disease, ulcerative colitis)
2. Life expectancy ≤12 months
3. Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant)
4. Patients who are enrolled in other trials that might mutually interfere
5. Not able to provide informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. 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.
2. Proportion of patients in intervention group at every dose reduction step (including discontinuation) at 6 and 12 months of follow up.
3. 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.
4. The cumulative incidence of patients experiencing a flare in each study group over the duration of the study.
5. Proportion of patients using csDMARD, corticosteroids or NSAIDs at baseline, and starting/changing these treatments during follow-up.
6. 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.
7. Association between possible predictors and outcome. Predictors will include baseline peak and trough JAKi concentrations and whole blood/PBMC immunophenotyping

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek Stichting

Sponsor organisation

Sint Maartenskliniek Stichting

Address

Hengstdal 3

City

Ubbergen

Postcode

6574 NA

Country

Netherlands

Scientific contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Researcher

Public contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Researcher

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications