Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial
EU CTIS ID: 2022-503119-40-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- -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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.