IXEKIZUMAB for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- adult age (≥ 18 years);\n- fulfilment of CASPAR criteria for PsA [2];\n- naïve to csDMARDs and/or bDMARDs;;\n- presence of active dactylitis, diagnosed and evaluated at each centre through physical examination"}

Exclusion criteria

• {"criterion_text":"-participation in another concurrent clinical intervention study within 30 days of randomization;\n- planned administration of live vaccines during the study period;\n- previous treatment with lymphocyte-depleting therapies or alkylating agents;\n- presence of one or more contraindication reported in datasheets of administered study drugs;\n- haemoglobin<9.0 g/dL, white-cell count<3.0×109/L, absolute neutrophil count<1.2×109/L, platelet count<100×109/L;\n- estimated glomerular filtration rate<40 ml/min (method of Cockcroft and Gault);\n- aspartate aminotransferase and/or alanine aminotransferase >1.5 times the upper normal range;\n- another autoimmune rheumatic disease except Sjogren’s syndrome;\n- recent, current, or chronic infection, including hepatitis B or hepatitis C infection or human immunodeficiency virus infection;\n- evidence of active, latent, or inadequately-treated Mycobacterium Tuberculosis infection;\n- a history of lymphoproliferative disorder;\n- major surgery within two weeks before starting study drugs, or having unhealed operation wounds;\n- history of cancer, except adequately treated, non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ;\n- Pregnant or lactating women (women of childbearing potential should have a negative test for HCG);\n- significant history of alcohol/drug abuse or addiction;\n- foreseeable inability to cooperate with given instructions and study procedures;\n- any condition precluding the administration of study drugs in compliance with datasheets indications;\n- any condition or laboratory parameter precluding the inclusion of the participant according to investigator."}

Primary endpoints

• {"endpoint_text":"- 1)\tTo assess the efficacy of ixekizumab monotherapy versus MTX monotherapy in PsA dactylitis\n- 2)\tTo evaluate the degree of response by using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis in PsA participants","definition_or_measurement_approach":"- Not specified for endpoint 1)\n- Endpoint 2): measured using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis"}

Italy

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

23

Number Of Sites

9

Number Of Participants

60

Primary sponsor

Full Name

Azienda Ospedaliera Ordine Mauriziano Di Torino

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Eli Lilly Italia","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Eli Lilly Italia S.p.A.,","duties_or_roles":"Source of monetary support","organisation_type":""}