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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01668004
Eligibility Criteria:
Inclusion Criteria:
* May not have been treated with GLM prior to study enrollment
* Must be able to provide retrospective data concerning extra-articular manifestations and episodes with a recall period of at least 12 months prior to anti-TNF use
* Must have definite AS according to the modified New York criteria in the Netherlands
* Must be candidate for treatment with anti-TNF agent according to the Assessment of SpondyloArthritis International Society (ASAS) consensus
* Must be able to adhere to dose and visit schedules
Exclusion Criteria:
* Any exclusion criteria stated in the Summary of Product Characteristics for golimumab
* Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01668004
Study Brief:
Protocol Section:
NCT01668004