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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT03738956
Eligibility Criteria:
Inclusion Criteria:
* The subjects will be considered if they fulfill the following criteria
1. Subjects greater than 18 years of age
2. Patients fulfilling the ASAS classification criteria for axial SpA including both non radiographic axial spondyloarthritis (nr-Ax SpA) and ankylosing spondylitis(AS)
3. Patients with axSpA underwent a trial of at least 2 course of NSAIDs with optimum doses for at least 1 month without response or with partial response
4. Patients with BASDAI ≥4 or ASDAS-CRP\>2.1
Exclusion Criteria:
* The subjects will be excluded if they have any of the
1. Systemic infections requiring hospital admission during the last 6 months
2. Active infections and/or a history of chronic or recurrent serious infective diseases, opportunistic infections
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. Serum creatinine \> upper limit of normal reference range
7. GFR less than 50 mL/min
8. Alanine aminotransaminase (ALT) more than 2 times of ULN
9. Pregnant or breast feeding females of child-bearing potential not using highly effective contraception
10. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
11. New York Heart Association Class III and IV congestive heart failure
12. 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:
NCT03738956
Study Brief:
Protocol Section:
NCT03738956