2022-503119-40-00RecruitingPhase 3
Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial
Azienda Ospedaliera Ordine Mauriziano Di Torino9 sites in 1 country60 target enrollmentStarted: April 23, 2025Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 9
- Primary Endpoint
- 1) To assess the efficacy of ixekizumab monotherapy versus MTX monotherapy in PsA dactylitis 2) To evaluate the degree of response by using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis in PsA participants
Study Overview
Brief Summary
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
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
1) To assess the efficacy of ixekizumab monotherapy versus MTX monotherapy in PsA dactylitis 2) To evaluate the degree of response by using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis in PsA participants
1) To assess the efficacy of ixekizumab monotherapy versus MTX monotherapy in PsA dactylitis 2) To evaluate the degree of response by using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis in PsA participants
Secondary Outcomes
No secondary outcomes reported
Investigators
Annamaria Iagnocco
Scientific
Azienda Ospedaliera Ordine Mauriziano Di Torino
Study Sites (9)
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