IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.
EU CTIS ID: 2025-521259-21-00
What this study is testing
The primary objective of the study is to evaluate if synovial biomarkers modifications in culture supernatants and cellular homogenates (after in vitro administration of IXE in assays of different cells/tissues obtained from refractory PsA patients) predict clinical response to systemic IXE at 12 weeks.
- 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
- 1. Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55); 2. Age greater than or equal to 18 years; 3. Active disease (defined as 3 or more swollen joints AND 3 or more tender joints); 4. Potential indication to (new) bDMARD therapy with IXE according to treating physician opinion, in line with international and national recommendations (3,57) and product data sheet; 5. Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events), naïve to b/tsDMARDs; 6. One of the involved joints has to be appropriate for US-guided synovial biopsy; 7. Patients must provide written informed consent; 8. Oral prednisone at doses of ≤10 mg/day (stable for at least 4 weeks); 9. No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks.
You likely can't join if
- 1. Contraindication to start a new bDMARD treatment course; 2. Previous treatment with bDMARDs (any, included anti-IL17A agents) or tsDMARDs (any); 3. Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics); 4. Previous treatment with intra-articular steroids within the previous 1 month; 5. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent; 6. Known allergy or hypersensitivity to any biologic therapy; 7. Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period; 8. Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin; 9. For women of childbearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after study completion; 10. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient; 11. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections; 12. Subjects with other autoimmune disease, e.g. Crohn's disease, Ulcerative colitis and Graves disease, except celiac disease and hypothyroidism which do not need to be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Italy
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, but 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.