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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT03880968
Eligibility Criteria:
Inclusion Criteria:
* aged between 18 years old and 65 years old with AS, according to 1984-revised New York classification criteria.
* an active disease of ASDAS with C reactive protein (ASDAS-CRP) ≥2.1.
* a disease duration of 6 months to 30 years.
* no exposure to biologics in recent 6 months before recruitment. Concomitant medications with NSAIDs, conventional disease modifying anti-rheumatic drugs (cDMARDs), or prednisone or a prednisone equivalent (≤10mg/day), were allowed to continue if they were maintained at a stable dose for 4 weeks or more from baseline.
Exclusion Criteria:
* late-stage patients with spinal fusion.
* patients with severe cardiac, hepatic, renal, hematologic or endocrine diseases.
* patients with a history of multiple sclerosis, current or past malignancy.
* patients who were pregnant, or planning to become pregnant, or breastfeeding.
* patients with active or recurrent infections, or those who required oral antibiotics 2 weeks or intravenous antibiotics 4 weeks before screening.
* patients with current or past or potential tuberculosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03880968
Study Brief:
Protocol Section:
NCT03880968