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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT03131661
Eligibility Criteria:
Inclusion Criteria:
* Participants must have a first or confirmed diagnosis of Spondyloarthritis (SpA) according to Assessment of Spondyloarthritis classification (ASAS) criteria
* Participants must be naïve to conventional, targeted and biological Disease modifying anti-rheumatic drugs (DMARDs) treatment
* Participants must understand the purpose of the study
* Participants must sign a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria:
* Participants who already started conventional, targeted and biological DMARDs treatment for SpA
* Participants who participate to an investigational study in the last 30 days
* Participants unwilling or unable to participate in long-term, 24 months, data collection
* Participants unwilling or unable to fill in the Participant-reported outcome (PRO) foreseen by the protocol
* Participants unwilling or unable to sign the informed consent to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03131661
Study Brief:
Protocol Section:
NCT03131661