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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT06370156
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
* Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs
Exclusion Criteria:
* Previously received biologic immunomodulating agents, except for those targeting TNF
* Previously been treated with three or more different TNF inhibitors
* Active, ongoing inflammatory diseases other than PsA
* Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
* A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
* History of ongoing, chronic or recurrent infections, or evidence of active TB infection
* History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)
* Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation
* Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT06370156
Study Brief:
Protocol Section:
NCT06370156