DAPHNE
Key facts
- Where
- Frederiksberg, Glostrup, Hellerup és Slagelse, DániaSee the 4 sites
- Phase
- 4. fázis
Where in Dánia
- Frederiksberg HospitalFrederiksberg, DániaNo longer taking part
- RigshospitaletGlostrup, DániaNo longer taking part
- Gentofte HospitalHellerup, DániaNo longer taking part
- Slagelse HospitalSlagelse, DániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rigshospitalet
- Trial code
- EU 2024-510746-14-00
- Record updated
- 2026. február 19.
- Original description
To assess the effect of ixekizumab (IXE) on the total inflammatory burden in the entire body (peripheral and axial joints and entheses) of patients with axSpA and PsA, as assessed by WB-MRIRead full original descriptionShow less
Detailed assessment of axial and peripheral entheses and joints in axial spondyloarthritis and psoriatic arthritis patients treated with ixekizumab – a 2-year study applying whole-body MRI, MRI-based synthetic CT, and CT
To assess the effect of ixekizumab (IXE) on the total inflammatory burden in the entire body (peripheral and axial joints and entheses) of patients with axSpA and PsA, as assessed by WB-MRI
Exclusion: Contraindications for ixekizumab. • Contraindication for MRI. • Previous exposure to ixekizumab or other biologic drug directly targeting IL-17 or IL-17 receptor • Has received more than 1 prior anti-TNF inhibitor • Previous exposure to other types of bDMARDs than TNF inhibitor. • Active inflammatory bowel disease • DMARDs are allowed during the study, but the dose cannot be changed from 1 month before the first MRI. • Use of any investigational drug and/or devices within 1 month before randomization or a period of 5 half-lives of the investigational drug, whichever is longer. • Any use of oral, intravenous, intra-articular, or intra-muscular corticosteroids within 1 month before the baseline MRI. • Pregnant or nursing (lactating) women. • Known recent drug or alcohol abuse. • Known severe psychiatric disease. • Incapable of complying with the examination program for physical or mental reasons. • Unable to speak, read, or understand Danish.