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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT02530268
Eligibility Criteria:
To be eligible for enrollment into the Corrona PsA-SpA Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.
Inclusion Criteria
The patient must be:
1. One of the following:
1. Diagnosed with psoriatic arthritis (PsA) and initiating (prescribed or starting) an eligible medication† for the treatment of PsA at the enrollment visit.
2. Meet the ASAS criteria for axial spondyloarthritis (AxSpA), including radiographic or non-radiographic, and initiating (prescribed or starting) an eligible biologic for the treatment of AxSpA at the enrollment visit.
3. Meet the modified New York classification criteria for ankylosing spondylitis (AS) and initiating (prescribed or starting) an eligible biologic for the treatment of AS at the enrollment visit
2. At least 18 years of age or older
3. Able and willing to provide written consent
Exclusion Criteria
The patient must not be:
1. Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis.
2. Participating in or planning to participate in a clinical trial with an interventional research study of a non-marketed or marketed investigational drug (e.g. phase I-IV clinical drug trial, post marketing study or registry study where drug is being provided). Of note, concurrent participation in another observational registry study is not excluded. ∆
* Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements at the time of enrollment. If the patient participated in the PsA-SpA registry and was exited to join a clinical trial, the patient cannot be re-enrolled in the PsA-SpA registry after clinical trial participation has ended.
Patients switching from an originator biologic to a biosimilar satisfy the enrollment eligibility requirement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02530268
Study Brief:
Protocol Section:
NCT02530268