Testing ixekizumab in adults with psoriatic arthritis not helped by prior treatment
Studies joint lining markers to see if they predict ixekizumab response in psoriatic arthritis.
Key facts
- Who runs it
- University Hospital Of Ferrara
- Where
- Ferrara, Monza, and Udine, ItalySee the 3 sites
- Trial code
- Registry title
- IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 30 people, planned
- Started
- 2 Jul 2025
- Expected to end
- 1 Apr 2027
- Type of study
- Interventional
- Record updated
- 10 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active psoriatic arthritis who did not respond to earlier conventional treatment and have not yet had biologic or targeted drugs. They would start ixekizumab.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed psoriatic arthritis (CASPAR criteria). Active disease: 3 or more swollen joints and 3 or more tender joints. At least one joint must be suitable for an ultrasound-guided biopsy of the joint lining.
- Earlier treatment
- At least 1 earlier csDMARD treatment that did not work well enough, lost effect or caused side effects. No earlier b/tsDMARD treatment. Prednisone 10 mg/day or less, stable for at least 4 weeks. No csDMARD, or a csDMARD stable for at least 4 weeks.
Main reasons for not taking part
- Any earlier treatment with biologic or targeted synthetic DMARDs, including anti-IL17A drugs
- Steroid injection into a joint within the last 1 month
- Live attenuated vaccine within 6 weeks, or planned during treatment
- Cancer in the last 5 years (except fully removed skin squamous or basal cell cancer)
- Serious infections, including untreated latent tuberculosis, hepatitis B or C, or HIV infection
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- University Hospital Of FerraraFerrara, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.
- Plain-language title
- Testing ixekizumab in adults with psoriatic arthritis not helped by prior treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 10 September 2026