Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04967950
Eligibility Criteria:
Inclusion Criteria:
* aged 18 years or older,;
* had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
* had at least 1 active enthesitis (confirmed by ultrasound) ;
* had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
* had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.
Exclusion Criteria:
* History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
* Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
* Peripheral neuropathy;
* Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
* recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) \>3x upper limit of normal (ULN) at screening; estimated creatinine clearance \<40 mL/min.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04967950
Study Brief:
Protocol Section:
NCT04967950