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Taking people in ItalyPhase 4

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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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