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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT06310057
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Patient fulfill the ASAS classification criteria for ax-SpA
3. Patient fulfill the definition of refractory axial ax-SpA
4. Patients with ASDAS-CRP\>2.1
Exclusion Criteria:
1. Patient currently taking or had prior treatment with bDMARD or tsDMARD (including JAK inhibitor)
2. Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis (including tuberculosis)
3. Hemoglobin (Hb) \< 9 g/dl
4. White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3
5. Live vaccines within 3 months prior to the first dose
6. GFR less than 50 mL/min
7. Alanine aminotransaminase (ALT) more than 2 times of ULN
8. Pregnant or breast feeding females of child-bearing potential not using highly effective contraception
9. Evidence or history of malignancy
10. New York Heart Association Class III and IV congestive heart failure
11. Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06310057
Study Brief:
Protocol Section:
NCT06310057