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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07339566
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged 18 years or older;
* Diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial spondyloarthritis;
* Ineffective or intolerant to NSAID therapy;
* Objective signs of inflammation (abnormal MRI or C-reactive protein);
* Active axial spondyloarthritis with BASDAI score ≥4 and BASDAI question 2 ≥4;
* Visual Analogue Scale (VAS) score ≥4;
Exclusion Criteria:
* Patients with radiographic evidence of sacroiliitis, bilateral ≥grade 2 or unilateral ≥grade 3;
* Presence of other active inflammations besides axial spondyloarthritis (e.g., active inflammatory bowel disease \[IBD\] or uveitis);
* Chest X-ray suggesting active infection or malignant lesions;
* Active systemic infection within 2 weeks prior to enrollment;
* Known tuberculosis, HIV, hepatitis B, or hepatitis C infection at screening;
* History of lymphoproliferative disease, any history of malignancy (within the past 5 years);
* Subjects with unstable cardiovascular disease;
* Patients taking potent opioid analgesics;
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07339566
Study Brief:
Protocol Section:
NCT07339566