2025-521259-21-00RecruitingPhase 4
IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.
University Hospital Of Ferrara3 sites in 1 country30 target enrollmentStarted: June 24, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12].
Study Overview
Brief Summary
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.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Treatment arm
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55);
- •Age greater than or equal to 18 years;
- •Active disease (defined as 3 or more swollen joints AND 3 or more tender joints);
- •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;
- •Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events), naïve to b/tsDMARDs;
- •One of the involved joints has to be appropriate for US-guided synovial biopsy;
- •Patients must provide written informed consent;
- •Oral prednisone at doses of ≤10 mg/day (stable for at least 4 weeks);
- •No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks.
Exclusion Criteria
- •Contraindication to start a new bDMARD treatment course;
- •Previous treatment with bDMARDs (any, included anti-IL17A agents) or tsDMARDs (any);
- •Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics);
- •Previous treatment with intra-articular steroids within the previous 1 month;
- •Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent;
- •Known allergy or hypersensitivity to any biologic therapy;
- •Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period;
- •Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin;
- •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;
- •Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient;
- •Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections;
- •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.
Outcomes
Primary Outcomes
The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12].
The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12].
Secondary Outcomes
- The secondary endpoints are: - Patient-level ultrasonographic response according to multi-joint PsASon22 US score (56), measured as 20% variation in the inflammatory subscore [Time point: T12]; - Joint level ultrasonographic response according to single-joint PsASon22 US score (56) [Time point: T12]; - Other key clinical endpoints (ACR50, ACR70, DAPSA, MDA, HAQ-DI score; PGA, pain, PhGA, number of swollen/tender joints, BSA) [Time points: T12, T24]; - Response to treatment according to ACR20 res
Investigators
Ettore Silvagni
Scientific
University Hospital Of Ferrara
Study Sites (3)
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