Ixekizumab for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- 1. Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55);"}
• {"criterion_text":"- 2. Age greater than or equal to 18 years;"}
• {"criterion_text":"- 3. Active disease (defined as 3 or more swollen joints AND 3 or more tender joints);"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- 5. Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events), naïve to b/tsDMARDs;"}
• {"criterion_text":"- 6. One of the involved joints has to be appropriate for US-guided synovial biopsy;"}
• {"criterion_text":"- 7. Patients must provide written informed consent;"}
• {"criterion_text":"- 8. Oral prednisone at doses of ≤10 mg/day (stable for at least 4 weeks);"}
• {"criterion_text":"- 9. No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks."}

Exclusion criteria

• {"criterion_text":"- 1. Contraindication to start a new bDMARD treatment course;"}
• {"criterion_text":"- 2. Previous treatment with bDMARDs (any, included anti-IL17A agents) or tsDMARDs (any);"}
• {"criterion_text":"- 3. Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics);"}
• {"criterion_text":"- 4. Previous treatment with intra-articular steroids within the previous 1 month;"}
• {"criterion_text":"- 5. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent;"}
• {"criterion_text":"- 6. Known allergy or hypersensitivity to any biologic therapy;"}
• {"criterion_text":"- 7. Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period;"}
• {"criterion_text":"- 8. Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- 10. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient;"}
• {"criterion_text":"- 11. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections;"}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59).","definition_or_measurement_approach":"Measured as ACR20 response at T12."}
• {"endpoint_text":"- 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].","definition_or_measurement_approach":"Laboratory test performance metrics (sensitivity, specificity, PPV, NPV, accuracy) of the test in predicting treatment response at T12."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Includes ultrasound-based responses (PsASon22 scores) at T12, various clinical response measures (ACR50/70, DAPSA, MDA, HAQ-DI, PGA, pain, PhGA, swollen/tender joint counts, BSA) at T12 and T24, and an additional ACR20-related response measure (text truncated in source)."}

Italy

Earliest CTIS Part Ii Submission Date

10-06-2025

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

14

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

University Hospital Of Ferrara

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy