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 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT02349295
Eligibility Criteria:
Inclusion Criteria:
* Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
* Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.
Exclusion Criteria:
* Current use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than 2 biologic DMARDs
* Current use of more than one cDMARDs
* Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02349295
Study Brief:
Protocol Section:
NCT02349295