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 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT03136861
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
* patients with back pain for at least 3 months and age of onset less than 45 years
* Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
* Spinal pain numeric rating scale score of more than 4 at Baseline.
* inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization
Key Exclusion Criteria:
* Chest X-ray or MRI with evidence of ongoing infectious or malignant process
* Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
* Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
* Active ongoing inflammatory diseases other than axial spondyloarthritis
* Other ongoing mechanical diseases affecting the spine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03136861
Study Brief:
Protocol Section:
NCT03136861