BridgeMD
DAPHNE
EU CTIS ID: 2024-510746-14-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria for both groups Age ≥ 18 years at the time of consent. Clinical indication for a biologic drug as assessed by the treating physician. Sufficient contraception for women. Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
- Inclusion criteria for patients with axSpA • AxSpA according to ASAS classification criteria for axSpA • Active inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert. • Total back pain as measured on a VAS scale ≥ 40 mm (0-100 mm) at baseline.
- Inclusion criteria for patients with PsA • PsA according to CASPAR criteria. • Negative rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP). • For patients with axial PsA involvement: o Imaging documented axial involvement on MRI, X-ray, or low-dose CT as judged by a central SpA imaging expert. • A minimum of 1 tender and swollen joint in addition to 2 further anatomical localizations with clinical signs of inflammation (i.e., tender enthesis and/or tender and/or swollen joint) assessed at screening and baseline.
You likely can't join if
- • 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.