BARICITINIB for Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis

Inclusion criteria

• {"criterion_text":"- Patients ≥ 16 years of age"}
• {"criterion_text":"- Clinical diagnosis of RA, PsA or axSpA"}
• {"criterion_text":"- Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose)"}
• {"criterion_text":"- 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

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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; assessed at 12 months of follow-up; proportion of patients in LDA in each study group."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean disease activity scores (DAS28-CRP for RA, PASDAS for PsA, ASDAS for axSpA) measured at 6 and 12 months."}
• {"endpoint_text":"- Proportion of patients in intervention group at every dose reduction step (including discontinuation) at 6 and 12 months of follow up.","definition_or_measurement_approach":"Proportion of intervention-group participants at each dose reduction step, including discontinuation, assessed at 6 and 12 months."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Cumulative incidence and incidence density of (treatment-related) adverse events across study duration; special focus on specified event types."}
• {"endpoint_text":"- The cumulative incidence of patients experiencing a flare in each study group over the duration of the study.","definition_or_measurement_approach":"Cumulative incidence of flares during the study period in each group."}
• {"endpoint_text":"- Proportion of patients using csDMARD, corticosteroids or NSAIDs at baseline, and starting/changing these treatments during follow-up.","definition_or_measurement_approach":"Proportion using specified concomitant medications at baseline and rates of initiation/change during follow-up."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Comparison of QoL and costs between groups; calculation of incremental cost-effectiveness ratio using between-group costs and QoL at specified timepoints."}
• {"endpoint_text":"- Association between possible predictors and outcome. Predictors will include baseline peak and trough JAKi concentrations and whole blood/PBMC immunophenotyping","definition_or_measurement_approach":"Association analyses between baseline predictors (including JAKi peak/trough concentrations and immunophenotyping) and outcomes."}

Netherlands

Earliest CTIS Part Ii Submission Date

20-06-2025

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

207

Number Of Sites

11

Number Of Participants

200

Primary sponsor

Full Name

Sint Maartenskliniek Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands