Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial
Key facts
- Where
- Ancona, Milan, Padova, Palermo, Pavia, Perugia, Roma, Rome és Turin, OlaszországSee the 9 sites
- Phase
- 3. fázis
Where in Olaszország
- Universita Politecnica Delle MarcheAncona, OlaszországToborzás még nem indult
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, OlaszországToborzás még nem indult
- Universita Degli Studi Di PadovaPadova, OlaszországToborzás még nem indult
- Universita' Degli Studi Di PalermoPalermo, OlaszországToborzás még nem indult
- 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, OlaszországToborzás még nem indult
- Università degli Studi di PerugiaPerugia, OlaszországToborzás még nem indult
- Policlinico Universitario Campus Bio-MedicoRoma, OlaszországToborzás még nem indult
- Azienda Sanitaria Locale Roma 1Rome, OlaszországToborzás még nem indult
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországToborzás még nem indult
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?
Trial details
- Who runs it
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Trial code
- EU 2022-503119-40-00
- Record updated
- 2025. április 23.
- Original description
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 scoreRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: -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.