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:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00844805
Eligibility Criteria:
Inclusion Criteria:
Participant must:
* be 18 to 48 years of age
* have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years.
* have active disease during trial enrollment
* have limited treatment history for axial spondyloarthritis (must meet certain criteria)
* agree to an acceptable method of contraception (for women of childbearing potential and all men)
* must meet certain tuberculosis screening requirements
* must meet certain laboratory screening safety requirements
* have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the Screening visit if site is outside of Germany).
Exclusion Criteria:
Participant will be excluded:
* for certain medical conditions and/or recent history of certain medical disorders
* for current or recent treatment with certain other medications and certain vaccinations.
* for being a woman who is breastfeeding, pregnant, or intending to become pregnant.
* if known to have had a substance abuse problem within the previous 3 years prior to screening.
* if currently participating in any other clinical study.
* for other administrative reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT00844805
Study Brief:
Protocol Section:
NCT00844805