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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT01877668
Eligibility Criteria:
Inclusion Criteria:
* Males or females, aged \>= 18 years at time of consent.
* Have a diagnosis of Psoriatic arthritis (PsA) of \>= 6 months
* Meet the Classification Criteria of PsA (CASPAR) at time of screening
* Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
* Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
* Must not have taken a biologic Tumour Necrosis Factor Inhibitor
* Must have 3 or more swollen joints AND 3 or more tender joints
* Must have active psoriasis skin lesions
Exclusion Criteria:
* Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
* Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
* New York Heart Association Class III and IV congestive heart failure
* History of hypersensitivity or infusion reaction to biologic agents
* Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01877668
Study Brief:
Protocol Section:
NCT01877668