Not yet taking people in ItalyPhase 3
Compares ixekizumab with methotrexate for finger swelling in psoriatic arthritis
Tests ixekizumab against methotrexate in adults with psoriatic arthritis and finger swelling.
Key facts
- Who runs it
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Where
- Ancona, Milan, Padova, Palermo, Pavia, Perugia, Roma, Rome, and Turin, ItalySee the 9 sites
- Trial code
- Registry title
- Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 60 people, planned
- Started
- 1 Dec 2025
- Expected to end
- 1 Dec 2027
- Type of study
- Interventional
- Record updated
- 23 April 2025
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 psoriatic arthritis who have active dactylitis (swollen fingers or toes) and have not had certain arthritis drugs before. It compares ixekizumab with methotrexate.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Psoriatic arthritis meeting the CASPAR criteria, with active dactylitis found at a physical exam at the centre
- Earlier treatment
- Must not have had csDMARDs and/or bDMARDs before. Must not have had lymphocyte-depleting therapies or alkylating agents.
Main reasons for not taking part
- Another autoimmune rheumatic disease, except Sjogren's syndrome
- Current or chronic infection, including hepatitis B, hepatitis C or HIV, or active or latent tuberculosis
- History of cancer (some skin cancers and cervical carcinoma in situ treated adequately are allowed)
- Pregnant or breastfeeding women
- Low blood counts, kidney function below 40 ml/min or raised liver tests (AST/ALT above 1.5 times the upper normal range)
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- adult age (≥ 18 years); - fulfilment of CASPAR criteria for PsA [2]; - naïve to csDMARDs and/or bDMARDs;; - presence of active dactylitis, diagnosed and evaluated at each centre through physical examination
Who cannot take part
- -participation in another concurrent clinical intervention study within 30 days of randomization; - planned administration of live vaccines during the study period; - previous treatment with lymphocyte-depleting therapies or alkylating agents; - presence of one or more contraindication reported in datasheets of administered study drugs; - haemoglobin<9.0 g/dL, white-cell count<3.0×109/L, absolute neutrophil count<1.2×109/L, platelet count<100×109/L; - estimated glomerular filtration rate<40 ml/min (method of Cockcroft and Gault); - aspartate aminotransferase and/or alanine aminotransferase >1.5 times the upper normal range; - another autoimmune rheumatic disease except Sjogren’s syndrome; - recent, current, or chronic infection, including hepatitis B or hepatitis C infection or human immunodeficiency virus infection; - evidence of active, latent, or inadequately-treated Mycobacterium Tuberculosis infection; - a history of lymphoproliferative disorder; - major surgery within two weeks before starting study drugs, or having unhealed operation wounds; - history of cancer, except adequately treated, non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ; - Pregnant or lactating women (women of childbearing potential should have a negative test for HCG); - significant history of alcohol/drug abuse or addiction; - foreseeable inability to cooperate with given instructions and study procedures; - any condition precluding the administration of study drugs in compliance with datasheets indications; - any condition or laboratory parameter precluding the inclusion of the participant according to investigator
Where in Italy
- Universita Politecnica Delle MarcheAncona, ItalyNot yet recruiting
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, ItalyNot yet recruiting
- Universita Degli Studi Di PadovaPadova, ItalyNot yet recruiting
- Universita' Degli Studi Di PalermoPalermo, ItalyNot yet recruiting
- Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. SbPavia, ItalyNot yet recruiting
- Università degli Studi di PerugiaPerugia, ItalyNot yet recruiting
- Policlinico Universitario Campus Bio-MedicoRoma, ItalyNot yet recruiting
- Azienda Sanitaria Locale Roma 1Rome, ItalyNot yet recruiting
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyNot yet recruiting
About the trial
What the trial wants to find out
The main aims of the present study are: i. to assess the efficacy of ixekizumab monotherapy versus methotrexate monotherapy in PsA dactylitis; ii. to evaluate the degree of response by using the DACTOS score
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
- Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial
- Plain-language title
- Compares ixekizumab with methotrexate for finger swelling in psoriatic arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 23 April 2025